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No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution
- 08033891327538 ()
81193
- Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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
VITROS Immunodiagnostic Products Anti-HBc IgM Controls
ORTHO CLINICAL DIAGNOSTICS
6801427
In Commercial Distribution
- 10758750001200 ()
- 20758750001207 ()
6801427
- Hepatitis B virus surface immunoglobulin M (IgM) antibody IVD, control
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
No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution
- 10627966005190 ()
- Influenza A/B virus antigen IVD, control
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
Not in Commercial Distribution
- 00404847437966 ()
EIA-3796
- Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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 Canada Inc
410200
Not in Commercial Distribution
- 00628055344117 ()
410200
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)