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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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
DR-HO's Perfect Back Rest This product is used for waist massage.Plastic injection molding into the ""S"" type, the external concave can better wrap the back of the human body, the middle part of the hemispherical origin, when the user by pressure, can be very good reaction force to the back, massage the effect.Products by the back, air cushion, fixed belt combination.
Guangzhou Xinbo Electronic Co., Ltd.
PBR-1
In Commercial Distribution

  • 06970742221473 ()


  • Back-filling orthosis
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005023 ()
KT022006

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ Testosterone 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 Testosterone Linearity Kit
In Commercial Distribution

  • 08809317540542 ()
FLK-TES

  • 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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