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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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ESR-Vacuum tubes - 00844509000006

1.2ml tri-sodium citrate blood collection tubes box contains 100 vials.
STRECK, INC.
240360
In Commercial Distribution

  • 00844509000006 ()

  • Total Volume: 1.2 Milliliter
240360

  • Evacuated blood collection tube IVD, sodium citrate

OraQuick In Home HIV Test - 00608337103403

No Description
Orasure Technologies, Inc.
1001-0340
In Commercial Distribution

  • 10608337103400 ()
  • 00608337103403 ()
  • 00608337000948 ()
  • 20608337103407 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

OraQuick In Home HIV Test, Pharmacy - 00608337001334

No Description
Orasure Technologies, Inc.
1001-0528
In Commercial Distribution

  • 10608337001331 ()
  • 00608337001334 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

OraQuick In Home HIV Test (Not for Resale) - 00608337000962

No Description
Orasure Technologies, Inc.
1001-0374
In Commercial Distribution

  • 10608337000969 ()
  • 00608337000962 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Intercept i2 Oral Fluid Collection Device - 00608337000917

No Description
Orasure Technologies, Inc.
3001-2661
In Commercial Distribution

  • 00608337000917 ()
  • 10608337000914 ()
  • 30608337000918 ()


  • Absorbent tipped applicator, non-sterile

OraSure QuickFlu Positive and Negative Control Kit - 00608337000054

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

OraSure Quickflu Nasopharyngeal Wash / Aspirate - 00608337000047

No Description
Orasure Technologies, Inc.
1001-0321
In Commercial Distribution

  • 00608337000047 ()


  • Influenza A/B virus antigen IVD, reagent
  • Nasopharyngeal aspirate container IVD

AIA-PACK βHCG Sample Diluting Solution - 04560189211360

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211360 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, reagent

AIA-PACK βHCG Calibrator Set - 04560189211353

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211353 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator

BUN Reagent Kit - 00386100001988

Blood Urea Nitrogen Reagent Kit for use with EasyRA Analyzers
MEDICA CORPORATION
10202-4
In Commercial Distribution

  • 00386100001988 ()
10202-4

  • Urea IVD, kit, enzyme spectrophotometry
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