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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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biokitHSV-2 - 08426951056439

20 Test Devices 20 x 0,7 ml Sample Diluent 20 x 0,5 ml Developing Reagent 20 x Empty Vials 1 20 x Pre-filter tips 20 x Capillary tubes 20 x Lancets 20 x Swabs 20 x Tube racks
BIOKIT, S.A.
300028001
Not in Commercial Distribution

  • 08426951056439 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Kalazar Detect Rapid Test for Visceral Leishmaniasis - B379INS0251

No Description
INBIOS INTERNATIONAL, INC
INS025
In Commercial Distribution

  • B379INS0251 ()
INS025

  • Leishmania donovani immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Chagas Detect™ Plus Rapid Test - B379CP0501

No Description
INBIOS INTERNATIONAL, INC
CP050
In Commercial Distribution

  • B379CP0501 ()
CP050

  • Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

SAS Herpes Check Test - 00780311000134

SAS Herpes Check lateral flow test kit is a visual and rapid assay for the qualitative detection of Herpes Simplex Virus Types 1 & 2 antigens in the eye and genital vesicular fluid.
SA SCIENTIFIC, LTD.
062002-W
In Commercial Distribution

  • 00780311000134 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Medline Industries, Inc. - 10889942118205

G PACK
MEDLINE INDUSTRIES, INC.
DYNJ48708B
In Commercial Distribution

  • 10889942118205 ()
DYNJ48708B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942333790

G PACK
MEDLINE INDUSTRIES, INC.
DYNJ48708C
In Commercial Distribution

  • 10889942333790 ()
DYNJ48708C

  • General surgical procedure kit, non-medicated, reusable

i-STAT - 10054749000118

G CARTRIDGE
ABBOTT POINT OF CARE INC.
03P83-25
In Commercial Distribution

  • 10054749000118 ()
  • 00054749000111 ()
03P83-25

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Vivid Nano Flow A 2 - D724D0102040

1 g
PEARSON DENTAL SUPPLIES, INC.
D010204
In Commercial Distribution

  • D724D0102040 ()


  • Light-cured dental restorative composite resin

Vivid Nano Flow bleach extra - D724D0102020

2 g
PEARSON DENTAL SUPPLIES, INC.
D010202
In Commercial Distribution

  • D724D0102020 ()


  • Light-cured dental restorative composite resin

PRIMO - 00840216121898

G&G ANGLED WEDGE BUNDLE BARIATRIC 14
Asp Global, LLC
GGTS14
In Commercial Distribution

  • 00840216121898 ()


  • Freestanding patient positioner, reusable
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