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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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Amphetamines Enzyme Immunoassay - B07600400

Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
0040
In Commercial Distribution

  • B07600400 ()
0040

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

Oral Fluid Amphetamine Enzyme Immunoassay - B076S0041B0

Large Test Kit. Antibody/Substrate Reagent (R1): 750 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
S0041b
In Commercial Distribution

  • B076S0041B0 ()
S0041b

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

Oral Fluid Amphetamine Enzyme Immunoassay - B076S0040B0

Small Test Kit. Antibody/Substrate Reagent (R1): 75 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
S0040b
In Commercial Distribution

  • B076S0040B0 ()
S0040b

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

Ecstasy Enzyme Immunoassay - B07601610

Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
0161
In Commercial Distribution

  • B07601610 ()
0161

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

DSG 1 & DSG 3 ELISA TEST - B110RGM7593D0

No Description
Bion Enterprises, Ltd.
RG-M7593-D
Not in Commercial Distribution

  • B110RGM7593D0 ()
RG-M7593-D

  • Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)

Alk Phos R2 (w/ssa#) - 00811727013743

For the quantitative determination of Alanine Aminotransferase in serum.
POINTE SCIENTIFIC, INC.
13-A7516-R2-30
In Commercial Distribution

  • 00811727013743 ()
13-A7516-R2-30

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Alk Phos R2 (w/ssa#) - 00811727013736

For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
13-A7516-R2-125
In Commercial Distribution

  • 00811727013736 ()
13-A7516-R2-125

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Alk Phos R1 (w/ssa#) - 00811727013729

For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
13-A7516-R1-500
In Commercial Distribution

  • 00811727013729 ()
13-A7516-R1-500

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Alk Phos R1 (w/ssa#) - 00811727013712

For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
13-A7516-R1-120
In Commercial Distribution

  • 00811727013712 ()
13-A7516-R1-120

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Albumin Std (w/ssa#) - 00811727013705

Intended for use as an albumin standard for standardization or calibration of bromocresol green (BCG) dye-binding albumin procedures.
POINTE SCIENTIFIC, INC.
13-A7502-STD
In Commercial Distribution

  • 00811727013705 ()
13-A7502-STD

  • Albumin IVD, kit, spectrophotometry
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