2016-05-05 Part No. B1017-201

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.

MicroScan Pos Combo Panel Type 21, Part No. B1017-201 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

2016-04-29 2016-05-04 Part No. B1017-211

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.

MicroScan Pos Combo Panel Type 33, Part No. B1017-211 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

2016-04-29 2016-05-06 Part No. B1017-214

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.

MicroScan Pos Combo Panel Type 34, Part No. B1017-214 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

2016-04-30 Part No. B1017-202

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.

MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

2016-05-06 Part No. B1017-206

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.

MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

Cat. no. K31 Lot no.15231

Immunology and Microbiology Devices

1

No

US. Distribution to the states of : CA, WI, MD and UT. .

FB Broth, 10ml || (Fastidious Bacteria Broth) || Cat. no: K31 Lot: 15231 || A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.

Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016

Immunology and Microbiology Devices

2

No

US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.

EliA SmDP Well, Article Number 14-5624-01 || Product Usage: || EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

SMN 10310292-100 test kits Lot# UDI # 54637263 0063041420300354637263160223 55304263 0063041420300355304263160223 56249264 0063041420300356249264160327 76727264 0063041420300376727264160327 00825265 0063041420300300825265160424 92416265 0063041420300392416265160424 99151265 0063041420300399151265160424 12970266 0063041420300312970266160721 14158266 0063041420300314158266160721 23016266 0063041420300323016266160721 28881266 0063041420300328881266160721 40776268 0063041420300340776268160922  SMN 10310293-500 test kits Lot# UDI # 54448263 0063041420299054448263160223 55171263 0063041420299055171263160223 56171264 0063041420299056171264160327 77560264 0063041420299077560264160327 92415265 0063041420299092415265160424 96996265 0063041420299096996265160424 12971266 0063041420299012971266160721 13429266 0063041420299013429266160721 19651266 0063041420299019651266160721 27278266 0063041420299027278266160721 35089266 0063041420299035089266160721 39805268 0063041420299039805268160922 50851268 0063041420299050851268160922

Immunology and Microbiology Devices

3

No

Worldwide - US Nationwide including Puerto Rico, OUS: Albania, Algeria, Angola, Armenia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Iraq, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, Turkmenistan, Unit.Arab Emir., Vatican, AR, AU, BD, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IL, IN, JP, KR, LK, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN and ZA.

ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) || Product Usage: || This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.

Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016.

Immunology and Microbiology Devices

1

No

Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.

BacT/ALERT¿ SN, bioM¿rieux, Inc. || Product Usage: || BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).

Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.

Immunology and Microbiology Devices

1

No

Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.

BacT/ALERT¿ FA, bioM¿rieux, Inc., || Product Usage: || BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).

Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16 Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16 Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16 Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16 Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16

Immunology and Microbiology Devices

1

No

Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, WY

API ZYM Bx2 (Ref 70493) || Product Usage: || ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.

Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign

Immunology and Microbiology Devices

2

No

Worldwide Distribution and US in the state of CA.

Dimension Vista System || B2 Microglobulin Flex reagent cartridge and urine stabilizer || Catalog #K7024 SMN: 10445889 Lot #15246MA || Product Usage: || The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Al lot codes

Immunology and Microbiology Devices

1

No

Nationwide Distribution.

NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube || Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

CODE(S):   a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016  b. Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016  c. Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016  d. Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016  e. Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016

Immunology and Microbiology Devices

3

No

Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.

QFT TB Antigen Tube. || QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)

Lots 736336020 exp. 2/25/16, 736340920 exp. 4/14/16, and 736388620 exp. 8/4/17.

Immunology and Microbiology Devices

2

No

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. || Product Usage: || The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262.  Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.   3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and United Kingdom.

Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) || Model Number: MOL2150, MOL1451, MOL1452, MOL1455

Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262.  Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.   3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and United Kingdom.

Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) || Model Number: MOL2650, MOL1451, MOL1452, MOL1455

Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262.  Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.   3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and United Kingdom.

Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) || Model Number: MOL2850, MOL1451, MOL1452, MOL1455

Lot/Serial: 485368220 Expiry: 12-JAN-17

Immunology and Microbiology Devices

2

No

Worldwide Distribution to China  Taiwan region; No US/military/government distribution.

VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. || VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Lots 739348620 exp. 6/30/16, 739348622 exp. 6/30/16, and 739348623 exp. 6/30/16.

Immunology and Microbiology Devices

2

No

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. || Product Usage: || The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Lots 740340920 exp. 4/14/16, 740350820 exp. 7/22/16, 740356320 exp. 9/15/16, 740361110 exp. 11/2/16, 740371720 exp. 2/16/17, 740386420 exp. 7/13/17, and 740388520 exp. 8/3/17.

Immunology and Microbiology Devices

2

No

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. || Product Usage: || The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Lots 741340920 exp. 4/14/16, 741350820 exp. 7/22/16, 741356320 exp. 9/15/16, 741357020 exp. 9/22/16, and 741366820 exp. 12/29/16.

Immunology and Microbiology Devices

2

No

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. || Product Usage: || The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Lots 742343610 exp. 5/11/16, 742347220 exp. 6/16/16, 742350010 exp. 7/14/16, 742352820 exp. 8/11/16, 742355710 exp. 9/9/16, 742362540 exp. 11/16/16, 742364020 exp. 12/1/16, 742368210 exp. 1/12/16, 742376540 exp. 4/5/17, 742383610 exp. 6/15/17, and 742389220 exp. 8/10/17.

Immunology and Microbiology Devices

2

No

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. || Product Usage: || The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Lots 743357720 exp. 9/29/16, 743366820 exp. 12/29/16, 743376510 exp. 4/5/17, 743380820 exp. 5/18/17, and 743387820 exp. 7/27/17.

Immunology and Microbiology Devices

2

No

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. || Product Usage: || The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Lots 744357740 exp. 9/29/16, 744383620 exp. 6/15/17, and 744389320 exp. 8/11/17.

Immunology and Microbiology Devices

2

No

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. || Product Usage: || The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.