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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)
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 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 International Inc
EIA-3796
In Commercial Distribution
- 00840239037961 ()
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 G
In Commercial Distribution
- 04049016028345 ()
- Influenza B virus immunoglobulin G (IgG) 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)
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)
The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.
The Alethia GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the Alethia GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections.
The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.
MERIDIAN BIOSCIENCE, INC.
480350
In Commercial Distribution
- 00840733102196 ()
480350
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
The illumigene Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.
The illumigene GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the illumigene GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections.
MERIDIAN BIOSCIENCE, INC.
280350
Not in Commercial Distribution
- 00840733101342 ()
280350
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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)