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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Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 10.0 mL bottle for approximately 1000 tests
Supertechs, Inc.
6100D
In Commercial Distribution

  • B7826100D03 ()
6100D

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 0.5 mL vial for approximately 50 tests
Supertechs, Inc.
6100A
In Commercial Distribution

  • B7826100A00 ()
6100

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
oncoReveal CDx Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Glycosylase (UDG), and Positive Control.
Pillar Biosciences, Inc.
HDA-LC-2001-48-1
In Commercial Distribution

  • 00860001218220 ()
HDA-LC-2001-48-1

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023
In Commercial Distribution

  • D801SP650231 ()
65-023

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023 B
In Commercial Distribution

  • D801SP65023B1 ()
65-023

  • Dentine adhesive
BD MAX™ CT/GC/TV Contains: 24 each, Master Mix, Extraction Tubes, Septum Caps, Strips-Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
BECTON, DICKINSON AND COMPANY
442970
Not in Commercial Distribution

  • 00382904429706 ()
442970

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
Opgen, Inc.
CP3402
Not in Commercial Distribution

  • 00812125010051 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodontically treated teeth. Whitepost System posts offer retention of direct and indirect materials, allowing for adequate rehabilitation.
Dentscare Ltda
DC 0.5 & 1 Refill Mix
In Commercial Distribution

  • 07899633831005 ()
4000055929

  • Root canal post, preformed
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Tropical Mix Colors b condoms
In Commercial Distribution

  • 00850281004385 ()
  • 00850281004583 ()


  • Basic male condom, Hevea-latex
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Tropical Mix Flavors b condoms
In Commercial Distribution

  • 00850281004378 ()
  • 00850281004576 ()


  • Basic male condom, Hevea-latex
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