Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

Show Filters

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
No Description
Bion Enterprises, Ltd.
QAB-1504
In Commercial Distribution

  • B110QAB15040 ()
QAB-1504

  • 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
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • 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
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
No Description
DIASORIN SPA
318130
In Commercial Distribution

  • 08056771103367 ()
  • 18056771103364 ()


  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
P001931
In Commercial Distribution

  • 08056771102360 ()


  • Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN SPA
P001929
In Commercial Distribution

  • 08056771102346 ()


  • Hepatitis B virus e-antigen total antibody IVD, kit, enzyme immunoassay (EIA)
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 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 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 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)
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)
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
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
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
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 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 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)
Solana GBS Assay
DIAGNOSTIC HYBRIDS, INC.
M311
In Commercial Distribution

  • 30014613336440 ()
M311

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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)
Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Xpert® Xpress GBS
CEPHEID
XPRSGBS-10
In Commercial Distribution

  • 07332940008161 ()
XPRSGBS-10

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
GBS LB XC
CEPHEID
GXGBSLBXC
In Commercial Distribution

  • 07332940007669 ()
GXGBSLBXC-120

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
GBS LB XC
CEPHEID
GXGBSLBXC
In Commercial Distribution

  • 07332940007652 ()
GXGBSLBXC-10

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert GBS LB kit; 10 test kit
CEPHEID
GXGBS-LB-10
In Commercial Distribution

  • 07332940000882 ()
GXGBS-LB-10

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert GBS LB kit; 120 test kit
CEPHEID
GXGBS-LB-120
In Commercial Distribution

  • 07332940000806 ()
GXGBS-LB-120

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert GBS kit; 10 test kit
CEPHEID
GXGBS-100N-10
In Commercial Distribution

  • 07332940000127 ()
GXGBS-100N-10

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
AmpliVue GBS Assay
QUIDEL CORPORATION
GBS Assay
Not in Commercial Distribution

  • 30014613312024 ()
M202

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
50 tests/kit
In Commercial Distribution

  • 06974849369281 ()


  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
48 tests/kit
In Commercial Distribution

  • 06974849369274 ()


  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
50 tests/kit
In Commercial Distribution

  • 06974849369267 ()


  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369250 ()


  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
50 tests/kit
In Commercial Distribution

  • 06974849369243 ()


  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing realtime PCR for detection of Group B Streptococcus DNA.
Hologic, Inc.
KIT, GBS ASSAY CARTRIDGES, 96-TEST, FUSION, IVD
In Commercial Distribution

  • 15420045510890 ()
PRD-04484

  • 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).
Gold Standard Diagnostics Frankfurt GmbH
INFG0300
In Commercial Distribution

  • ENTIINFG03000 ()
INFG0300

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
C. diff Assay Cartridge and Sample Prep Device.
GREAT BASIN SCIENTIFIC, INC.
GBCDIFF-10
In Commercial Distribution

  • B178GBCDIFF100 ()
  • B178GBCDIFF102 ()
GBCDIFF-10

  • Clostridium difficile toxin B nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Water Seal CPAP Valve, 24 units
B&B Medical Technologies
25324
In Commercial Distribution

  • 00850008733055 ()
25324

  • PEEP valve, single-use
Water Seal CPAP Valve, 12 units
B&B Medical Technologies
25312
In Commercial Distribution

  • 00850008733031 ()
25312

  • PEEP valve, single-use
No Description
Lgc Clinical Diagnostics, Inc.
2000-0107
In Commercial Distribution

  • 00850041090108 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0106
In Commercial Distribution

  • 00850041090092 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0105
In Commercial Distribution

  • 00850041090061 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
< 1 ... 13 14 15 16 17 ... 200 >