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Blood Grouping Reagent, ALBAclone Anti-Leb (Murine Monoclonal IgM) for tube technique.
ALBA BIOSCIENCE LIMITED
Z217U
In Commercial Distribution
- 05060242471049 ()
- Anti-Le^b red blood cell grouping IVD, antibody
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)
Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
MICROBIOLOGICS INC.
200250
Not in Commercial Distribution
- 10634853000022 ()
200250
- Blastomyces dermatitidis exoantigen IVD, control
Blastomyces dermatitidis Antigen (A), 1mL
MICROBIOLOGICS INC.
200125
Not in Commercial Distribution
- 10634853000015 ()
200125
- Blastomyces dermatitidis total antibody IVD, control
Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
SAVYON DIAGNOSTICS LTD
A2231-01M
In Commercial Distribution
- 07290016332636 ()
A2231-01M
- Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SEKISUI DIAGNOSTICS, LLC
191
Not in Commercial Distribution
- 00742860100147 ()
- 10742860100144 ()
191
- Influenza A/B virus antigen IVD, control
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
OSOM Ultra Flu A&B Controls 5 Test
SEKISUI DIAGNOSTICS, LLC
1005
In Commercial Distribution
- 00742860100215 ()
- 10742860100212 ()
1005
- Influenza A/B virus antigen IVD, control
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 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)
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)
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
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)
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)
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 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)
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
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution
- 08033891327538 ()
81193
- 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 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)
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)
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)