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BD® CD19 (4G7) PE
Becton, Dickinson And Company
349209
In Commercial Distribution
- 00382903492091 ()
349209
- Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
No Description
SEKISUI DIAGNOSTICS, LLC
1034
In Commercial Distribution
- 10742860100403 ()
- 00742860100406 ()
- Influenza A/B virus antigen IVD, control
No Description
SEKISUI DIAGNOSTICS, LLC
1011
In Commercial Distribution
- 00742860100383 ()
- 10742860100380 ()
- Influenza A/B virus antigen IVD, control
The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM Broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes Automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. it is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
MERIDIAN BIOSCIENCE, INC.
410200
In Commercial Distribution
- 00840733102363 ()
410200
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Control Swabs ntended for use only with BinaxNOW™ Influenza A & B 2 Card product.
Alere Scarborough, Inc.
575-080
In Commercial Distribution
- 10811877010989 ()
- Influenza A/B virus antigen IVD, control
The Control Swabs are intended for use only with the Alere Influenza A & B Test.
Alere Scarborough, Inc.
412-080
Not in Commercial Distribution
- 10811877010880 ()
- Influenza A/B virus antigen IVD, control
Control Swabs intended for use only with Alere BinaxNOW® Influenza A & B Card 2 product.
Alere Scarborough, Inc.
575-080
Not in Commercial Distribution
- 10811877010194 ()
- Influenza A/B virus antigen IVD, control
DS5 HbA1c Calibrator (1 and 2) (2 x 4 x 0.5mL)
DREW SCIENTIFIC, INC.
014-380SA
In Commercial Distribution
- 00817274020210 ()
- Hepatitis B virus e-antigen total antibody IVD, calibrator
DS5 HbA1c Calibrator (4x 0.5mL L1, 4x 0.5mL L2, 1x 6mL Diluent)
DREW SCIENTIFIC, INC.
014-380
In Commercial Distribution
- 00817274020203 ()
- Hepatitis B virus e-antigen total antibody IVD, calibrator
No Description
GREAT BASIN SCIENTIFIC, INC.
GBGBS-10
In Commercial Distribution
- B178GBGBS100 ()
- B178GBGBS102 ()
GBGBS-10
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)