GENTAMICIN

Lot Number M804552

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV, and countries of Canada, Belgium, Denmark, France, Germany, Ireland, Lithuania, Netherlands, Spain, Switzerland, United Kingdom, New Zealand, Singapore, Egypt, South Africa, Taiwan, and United Arab Imarets.

SYNCHRON Gentamicin (GEN) Reagent || GEN reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 3 Plus, is intended for quantitative determination of Gentamicin concentration in

Oxoid Antimicrobial Susceptibility Testing Disc CN10 (Gentamicin), CT0024B

All Lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 || This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

.Lot #s: 1866567 2492886 2844909 3106436 3299572 3434618 F049Z40 1890991 2521804 2866892 3115022 3310546 3466958 1927220 2585596 2888115 3134757 3339992 3475370 1933603 2589374 2889319 3166736 3347549 3483245 1985488 2589379 2981608 3175434 3362229 3498627 2047388 2610503 2991395 3205074 3378764 3528522 2064474 2610505 3011228 3223183 3380098 3572240 2332458 2641279 3042105 3236354 3403313 3572270 2354798 2803352 3062608 3249497 3412748 3590469 2374539 2839097 3078622 3249526 3416122 F024ZA40

Orthopedic Devices

2

Yes

Distributed in Puerto Rico and US Virgin Islands.

SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. || SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.

List # 9512-60 / Lot # 51187Q100 Exp Date: 09/17/08

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide, USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii and Puerto Rico, an countries of Canada, Mexico, Guatemala, Germany, Australia, Japan, Singapore, Hong Kong, Taiwan, South Korea, and New Zeland.

Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064