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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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The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL.
ARK DIAGNOSTICS INC
5055-0001-00
In Commercial Distribution

  • 00812101030349 ()
5055-0001-00

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
ARK™ UR-144/JWH-018 Negative Calibrator is intended for use in calibration of the ARK™ UR-144/JWH-018 Assay.
ARK DIAGNOSTICS INC
5054-0002-01
In Commercial Distribution

  • 00812101030264 ()
5054-0002-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator
The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of UR-144/JWH-018 and their metabolites in human urine at a cutoff concentration of 10 ng/mL.
ARK DIAGNOSTICS INC
5054-0001-01
In Commercial Distribution

  • 00812101030257 ()
5054-0001-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of UR-144/JWH-018 and their metabolites in human urine at a cutoff concentration of 10 ng/mL.
ARK DIAGNOSTICS INC
5054-0001-00
In Commercial Distribution

  • 00812101030240 ()
5054-0001-00

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
For the quantitative determination of urea nitrogen in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only. 3 x 40ml, 3 x 10ml
Medtest Dx, Inc.
BUN600
In Commercial Distribution

  • 00817439020307 ()
BUN600

  • Urea IVD, kit, enzyme spectrophotometry
For the quantitative determination of urea nitrogen in serum using the Polychem 180 analyzer. For in vitro diagnostic use only. 6 x 51 ml, 4 x 20 ml
Medtest Dx, Inc.
BUN505
In Commercial Distribution

  • 00817439020291 ()
BUN505

  • Urea IVD, kit, enzyme spectrophotometry
For the quantitative determination of urea nitrogen in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. 8 x 60 ml, 8 x 15 ml
Medtest Dx, Inc.
BUN480
In Commercial Distribution

  • 00817439020284 ()
BUN480

  • Urea IVD, kit, enzyme spectrophotometry
For the quantitative in vitro determination of Alanine Aminotransferase (ALT) in serum and plasma. 6 x 51 ml, 6 x 14 ml
Medtest Dx, Inc.
ALT505
In Commercial Distribution

  • 00817439020161 ()
ALT505

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
For the quantitative determination of alkaline phosphatase in human serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device. 5 x 60 ml, 5 x 15 ml.
Medtest Dx, Inc.
ALT480
In Commercial Distribution

  • 00817439020154 ()
ALT480

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Core Material; Mini-Mix Syringe Kit: Shades: A2, A3, Gold, Blue, Opaceous White
Kerr Corporation
N32F
In Commercial Distribution

  • 00814978023240 ()

  • Total Volume: 20 Milliliter


  • Self-cured dental restorative composite resin
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