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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

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StrepAim - 00695684755256

A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs
GERMAINE LABORATORIES, INC
75525
In Commercial Distribution

  • 00695684755201 ()
  • 00695684755256 ()


  • Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)

STREPAIM - 00695684730406

A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs.
GERMAINE LABORATORIES, INC
73040
In Commercial Distribution

  • 00695684730406 ()
  • 00695684730401 ()


  • Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)

STREPAIM - 00695684730253

A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs.
GERMAINE LABORATORIES, INC
73025
In Commercial Distribution

  • 00695684730253 ()
  • 00695684730215 ()


  • Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)

Fort Worth Diagnostics - 00850051429653

Influenza A H5N1 Control 1E5 cp/mL
Fort Worth Diagnostics, LLC
H5N1POS
In Commercial Distribution

  • 00850051429653 ()
H5N1POS

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, control

Trinity Biotech - 05391516743686

Captia™ H. pylori IgA
CLARK LABORATORIES, INC.
2326430
In Commercial Distribution

  • 05391516743686 ()

  • 96 Tests
2326430

  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

DSQ Alert® HT HAV Probe Mix ASR - 03661540952890

Product Description DSQ Alert® HT HAV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’ UTR of HAV. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP530 fluorophore and has an excitation wavelength maximum of 530 nm and an emission wavelength maximum of 550 nm. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800816
In Commercial Distribution

  • 03661540952890 ()
M800816

  • Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT)

DSQ Alert™ HT HAV Primer Mix ASR - 03661540952883

Product Description DSQ Alert® HT HAV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ UTR of HAV. The mix consists of a total of 23.4 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 90 bp region of the 5’ UTR of HAV. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800815
In Commercial Distribution

  • 03661540952883 ()
M800815

  • Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ABX PENTRA ASO CP - 03610230005811

No Description
HORIBA ABX SAS
1220001980
In Commercial Distribution

  • 03610230005811 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

LIAISON® HAV IgM - 08056771100212

No Description
DIASORIN SPA
310210
In Commercial Distribution

  • 08056771100212 ()


  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

QUANTA Lite® H.pylori IgA ELISA - 08426950593805

1. 1x H. pylori IgA ELISA microwell plate, (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgA ELISA Low Positive 4. 1x 1.2mL prediluted H. pylori IgA ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708720
In Commercial Distribution

  • 08426950593805 ()


  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
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