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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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Alinity m - 00884999047754

Alinity m HBV AMP Kit
ABBOTT MOLECULAR INC.
08N47-095
In Commercial Distribution

  • 00884999047754 ()
08N47-095

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

Vysis - 00884999000735

Vysis Paraffin Pretreatment IV & Post-Hybridization Wash Buffer Kit
ABBOTT MOLECULAR INC.
01N31-005
In Commercial Distribution

  • 00884999000735 ()
01N31-005

  • Nucleic acid hybridization detection IVD, reagent

GS - 00847865001861

HBsAg EIA 3.0 Conjugate Diluent, 120 mL
Bio-RAD Laboratories, Inc.
25104
In Commercial Distribution

  • 00847865001861 ()

  • Total Volume: 120 Milliliter
25104

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

GEM 21S® - 00850001118002

Growth-Factor Enhanced Matrix for Periodontal Regeneration
LYNCH BIOLOGICS, LLC
LBGEM05
In Commercial Distribution

  • 00850001118002 ()

  • Weight: 0.5 Gram


  • Periodontal root surface regeneration material

MONOLISA™ - 00847865002103

Anti-HBs EIA, Conjugate Diluent 15 mL
Bio-RAD Laboratories, Inc.
26155
In Commercial Distribution

  • 00847865002103 ()

  • Total Volume: 15 Milliliter
26155

  • Hepatitis B virus surface total antibody IVD, reagent

THxID™-BRAF - 03573026354909

The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative detection of the BRAF V600E and V600K mutations in human melanoma tissue
BIOMERIEUX SA
410697
In Commercial Distribution

  • 03573026354909 ()
410697

  • BRAF gene mutation IVD, kit, nucleic acid technique (NAT)

BELLAFILL - 00350224000141

Bellafill 1.5ml on 1.5cc syringe
SUNEVA MEDICAL, INC.
1.5 cc
In Commercial Distribution

  • 10350224000148 ()
  • 00350224000141 ()
  • 20350224000145 ()
  • 30350224000142 ()
GBF0115, GBF0215, GBF0315

  • Dermal tissue reconstructive material, animal-derived

SKIN TEST - 00350224000035

Skin Test 0.3ml in 1.0cc syringe
SUNEVA MEDICAL, INC.
0.3cc
In Commercial Distribution

  • 10350224000032 ()
  • 00350224000035 ()
  • 20350224000039 ()
GBS0501

  • Dermal tissue reconstructive material, animal-derived

BELLAFILL - 00350224000028

Bellafill 0.8ml on 1.0cc syringe
SUNEVA MEDICAL, INC.
1.0 cc
In Commercial Distribution

  • 00350224000028 ()
  • 10350224000025 ()
  • 20350224000022 ()
GBF0208, GBF0508

  • Dermal tissue reconstructive material, animal-derived

ARTEFILL - 00350224000004

No Description
SUNEVA MEDICAL, INC.
8021
Not in Commercial Distribution

  • 00350224000004 ()
  • 10350224000001 ()
AF0508

  • Dermal tissue reconstructive material, animal-derived
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