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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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1,25-Dihydroxy Vitamin D EIA - 05060169690097

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
AC-62F1
In Commercial Distribution

  • 05060169690097 ()


  • 1,25-Dihydroxy vitamin D3 IVD, reagent

Ostase®+ BAP EIA - 05060169690059

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
AC-20F1
In Commercial Distribution

  • 05060169690059 ()


  • Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay

STELA - 09336472002398

STELA CAPSULES INTRO KIT
SDI LIMITED
8640004
In Commercial Distribution

  • 09336472002398 ()
8640004

  • Dental composite resin

STELA - 09336472002374

STELA AUTOMIX INTRO KIT
SDI LIMITED
8640002
In Commercial Distribution

  • 09336472002374 ()
8640002

  • Dental composite resin

Set - 09336472018535

SET ASSORTED KT
SDI LIMITED
8810000
In Commercial Distribution

  • 09336472018535 ()
8810000

  • Dental composite resin

Set - 09336472018290

SET OA3 50 CAP
SDI LIMITED
8805003
In Commercial Distribution

  • 09336472018290 ()
8805003

  • Dental composite resin

Set - 09336472018283

SET A2 50 CAP
SDI LIMITED
8805002
In Commercial Distribution

  • 09336472018283 ()
8805002

  • Dental composite resin

Set - 09336472018276

SET A1 50 CAP
SDI LIMITED
8805001
In Commercial Distribution

  • 09336472018276 ()
8805001

  • Dental composite resin

AccuDiag ™ - 00894175000237

AccuDiag ™ dsDNA Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
Diagnostic Automation, Inc.
DACD-2553-1
In Commercial Distribution

  • 00894175000237 ()
2553-1

  • Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA)

AccuDiag ™ - 00894175000008

AccuDiag ™ IFA FTA-ABS Test System - Treponema pallidum total antibody IVD, kit, Fluorescent Immunoassay Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
Diagnostic Automation, Inc.
DACD-351010
In Commercial Distribution

  • 00894175000008 ()

  • 10x10 wells
351010

  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay
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