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The GenePOC™ 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 GenePOC 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 GenePOC 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..
GenePoc Inc
130932
Not in Commercial Distribution
- 00628055344018 ()
130932
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
aHBs Calibration Verification / Linearity Test kit
Lgc Clinical Diagnostics, Inc.
801mm
In Commercial Distribution
- 00850011135495 ()
- Hepatitis B virus surface immunoglobulin G (IgG) antibody IVD, control
The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.
LUMINEX CORPORATION
50-10021
Not in Commercial Distribution
- 00840487100165 ()
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity s Anti-HBc Reagent Kit
Abbott GmbH
06P0660
In Commercial Distribution
- 00380740117207 ()
06P0660
- Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
ABBOTT PRISM HBcore Assay Kit
ABBOTT LABORATORIES
6E66-68
Not in Commercial Distribution
- 00380740062965 ()
06E6668
- Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 G
In Commercial Distribution
- 04049016028345 ()
- Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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
In Commercial Distribution
- 04048474037968 ()
EIA-3796
- Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 M
Not in Commercial Distribution
- 04049016028352 ()
- Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 A
Not in Commercial Distribution
- 04049016028338 ()
- Influenza B virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
BD MAX™ GBS
BECTON, DICKINSON AND COMPANY
441772
In Commercial Distribution
- 00382904417727 ()
441772
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)