Company Name Brand Name GMDN Term FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class

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PMK VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-308
In Commercial Distribution

  • 30014613331391 ()
15-308

  • Cell culture line IVD
RMK SV5/SV40 TUBE
DIAGNOSTIC HYBRIDS, INC.
14-309
In Commercial Distribution

  • 30014613331384 ()
14-309

  • Cell culture line IVD
RMK TUBE
DIAGNOSTIC HYBRIDS, INC.
14-308
In Commercial Distribution

  • 30014613331377 ()
14-308

  • Cell culture line IVD
Hela, MWP, 96W24F
DIAGNOSTIC HYBRIDS, INC.
72-9624C
In Commercial Distribution

  • 30014613339571 ()
72-9624C

  • Cell culture line IVD
VERO SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
84-0101
In Commercial Distribution

  • 30014613339564 ()
84-0101

  • Cell culture line IVD
Vero E6, MWP, 96W96F 90% conf
DIAGNOSTIC HYBRIDS, INC.
50-91-9696-90
In Commercial Distribution

  • 30014613339281 ()
50-91-9696-90

  • Cell culture line IVD
Vero E6, MWP, 96W96F
DIAGNOSTIC HYBRIDS, INC.
91-9696
In Commercial Distribution

  • 30014613339274 ()
91-9696

  • Cell culture line IVD
FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.
NanoEnTek, Inc.
FREND Blocking Reagent
In Commercial Distribution

  • 08809317540825 ()
FRBR 015

  • Immunohistochemistry endogenous protein blocking reagent IVD
FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND Vitamin D Linearity Kit
In Commercial Distribution

  • 08809317540566 ()
FLK-VTD

  • Non-blood cell primer/calibrator/control material IVD, reagent
FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND TSH Linearity Kit
In Commercial Distribution

  • 08809317540559 ()
FLK-TSH

  • Non-blood cell primer/calibrator/control material IVD, reagent
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