Becton Dickinson & Co.

Lot 08T13108 Exp Dec 24 2013

Immunology and Microbiology Devices

1

No

US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.

BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** || The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD.

Lot Number/ Exp. Date  3070436 September 12, 2014 3042466 August 16, 2014 3053239 August 30, 2014 3053240 August 30, 2014 3061013 September 6, 2014 3061014 September 6, 2014 3070433 September 12, 2014 3070437 September 12 , 2014

Immunology and Microbiology Devices

1

No

USA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WI

BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part || Product Usage: || The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

Serial Numbers:  MX0001 to MX0065  CM0001 to CM0105  NOTE: Serial numbers are assigned sequentially. The above ranges will include all sequential numbers in between the beginning and end points.

Immunology and Microbiology Devices

1

No

USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.

Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.

Lot number 2089253

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico

BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***

not coded

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA including CA, MA, MD, VA and the countries of Argentina, Colombia, Belgium, China, India, Hong Kong, Peru, Singapore, Thailand, and Trinidad.

BACTEC(tm) MGIT(tm) 2-Tube Spare AST Set Carrier, Bag of 3, Catalog 445946. ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152*** || The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.