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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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Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB56110 ()
BSB 5611

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56100 ()
BSB 5610

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0105
In Commercial Distribution

  • 00816784020628 ()

  • Total Volume: 20 Milliliter
2020-0105

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0104
In Commercial Distribution

  • 00816784020611 ()

  • Total Volume: 5 Milliliter
2020-0104

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
96 Test enzyme immunoassay kit for the determination of FIX Antigen
Affinity Biologicals Inc
FIX-AG
In Commercial Distribution



  • Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1001-0323
In Commercial Distribution

  • 00608337000054 ()


  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
Status Flu Control Kit (5 Flu A/5 Flu B)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-02
In Commercial Distribution

  • 10743816001423 ()
BSP-510C-02

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
BioSign Flu Control Kit (5 Postive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-03
In Commercial Distribution

  • 10743816001492 ()
BSP-510C-03

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
320 P37,SY,2L,2LD,TV & LT COM TIED,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-991-144
In Commercial Distribution

  • 00840828100847 ()
229

  • Electrical mains power extension cable
No Description
FUJIREBIO INC.
231753
In Commercial Distribution

  • 04987270231753 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay
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