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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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Uric Acid Reagent - 00812137012050

For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. The determination of uric acid in serum is most commonly performed for the diagnosis of gout. Increased uric acid levels are also found in leukemia, polycythemia, familial idiopathic hyperuricemia, and conditions associated with decreased renal function.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
500mL
In Commercial Distribution

  • 00812137012050 ()
501-418

  • Uric acid IVD, reagent

ZEOS - 00812231031605

ZEOS ZOOM COUPLER, F=16-34MM
SANTA BARBARA IMAGING SYSTEMS, INC.
84-10-2220
In Commercial Distribution

  • 00812231031858 ()
  • 00812231031605 ()
84-10-2220

  • Endoscope camera adaptor

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)

Ecstasy Enzyme Immunoassay - B07601600

Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
0160
In Commercial Distribution

  • B07601600 ()
0160

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

Amphetamines 500 Enzyme Immunoassay - B07601010

Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
0101
In Commercial Distribution

  • B07601010 ()
0101

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

Amphetamines 500 Enzyme Immunoassay - B07601000

Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
0100
In Commercial Distribution

  • B07601000 ()
0100

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

Amphetamines Enzyme Immunoassay - B07600410

Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
0041
In Commercial Distribution

  • B07600410 ()
0041

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

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)

Pointe Ecstasy (MDMA) Reagent Set - 00811727018007

Pointe Ecstasy (MDMA) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ecstasy (MDMA) Reagent Set is intended for the qualitative and semi-quantitative determination of MDMA and related compounds in human urine at a cutoff value of 500 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-EC0320-1L
In Commercial Distribution

  • 00811727018007 ()
60-EC0320-1L

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

Pointe Ecstasy (MDMA) Reagent Set - 00811727017994

Pointe Ecstasy (MDMA) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ecstasy (MDMA) Reagent Set is intended for the qualitative and semi-quantitative determination of MDMA and related compounds in human urine at a cutoff value of 500 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-EC0320-100
In Commercial Distribution

  • 00811727017994 ()
60-EC0320-100

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

Pointe Amphetamines 1000 Reagent Set - 00811727016621

Pointe Amphetamines 1000 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Amphetamines 1000 Reagent Set is intended for the qualitative and semi-quantitative determination of methamphetamine and amphetamine in human urine at a cutoff value of 1000 ng/mL when calibrated with d-methamphetamine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-AM0080-1L
In Commercial Distribution

  • 00811727016621 ()
60-AM0080-1L

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

Pointe Amphetamines 1000 Reagent Set - 00811727016614

Pointe Amphetamines 1000 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Amphetamines 1000 Reagent Set is intended for the qualitative and semi-quantitative determination of methamphetamine and amphetamine in human urine at a cutoff value of 1000 ng/mL when calibrated with d-methamphetamine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-AM0080-100
In Commercial Distribution

  • 00811727016614 ()
60-AM0080-100

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

Pointe Amphetamines 500 Reagent Set - 00811727016546

Pointe Amphetamines 500 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Amphetamines 500 Reagent Set is intended for the qualitative and semi-quantitative determination of methamphetamine and amphetamine in human urine at a cutoff value of 500 ng/mL when calibrated with d-methamphetamine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-AM0200-1L
In Commercial Distribution

  • 00811727016546 ()
60-AM0200-1L

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

Pointe Amphetamines 500 Reagent Set - 00811727016539

Pointe Amphetamines 500 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Amphetamines 500 Reagent Set is intended for the qualitative and semi-quantitative determination of methamphetamine and amphetamine in human urine at a cutoff value of 500 ng/mL when calibrated with d-methamphetamine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-AM0200-100
In Commercial Distribution

  • 00811727016539 ()
60-AM0200-100

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

Pointe Scientific, Inc. Uric Acid - 00811727015136

Pointe Scientific, Inc. Uric Acid Reagent is for the quantitative determination of Uric Acid in serum. Packaged for use on Olympus Analyzers. For in vitro diagnostic use only. 9 x 65ml, 8 x 16ml
POINTE SCIENTIFIC, INC.
OU982-713
In Commercial Distribution

  • 00811727015136 ()
OU982-713

  • Uric acid IVD, reagent

Pointe Scientific, Inc. Uric Acid - 00811727014849

Pointe Scientific, Inc. Uric Acid Reagent is for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. 1 x 1L, 1 x 250ml
POINTE SCIENTIFIC, INC.
HU982-1250
In Commercial Distribution

  • 00811727014849 ()
HU982-1250

  • Uric acid IVD, reagent

Pointe Scientific, Inc. - 00811727014467

Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Size: 1 x 500 mL
POINTE SCIENTIFIC, INC.
13-U7581-500
In Commercial Distribution

  • 00811727014467 ()
13-U7581-500

  • Uric acid IVD, reagent

Pointe Scientific, Inc. - 00811727014450

Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Size: 1 x 120 mL
POINTE SCIENTIFIC, INC.
13-U7581-120
In Commercial Distribution

  • 00811727014450 ()
13-U7581-120

  • Uric acid IVD, reagent

Pointe Scientific, Inc. - 00811727013330

IgE for the quantitative determination of Immunoglobulin E (IgE) concentration in human serum. For in vitro diagnostic use only. 96 Tests.
POINTE SCIENTIFIC, INC.
P1035-96
In Commercial Distribution

  • 00811727013330 ()
P1035-96

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

Pointe Scientific, Inc. Uric Acid - 00811727013125

Uric Acid is for the quantitative determination of uric acid in serum on Hitachi analyzers. For in vitro diagnostic use only. 9 x 65ml, 9 x 16ml.
POINTE SCIENTIFIC, INC.
HU982-729
In Commercial Distribution

  • 00811727013125 ()
HU982-729

  • Uric acid IVD, reagent

Pointe Uric Acid Reagent - 00811727016294

Pointe Uric Acid Reagent packaged for use on the Mindray BA800. 4 x 65ml R1, 3 x 16ml R2. For the quantitative determination of uric acid in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
16-HU982-308
In Commercial Distribution

  • 00811727016294 ()
16-HU982-308

  • Uric acid IVD, reagent

Pointe Uric Acid Reagent - 00811727015990

Pointe Uric Acid Reagent packaged for use on the Mindray BS480. 4 x 40ml. For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
14-U7581-160
In Commercial Distribution

  • 00811727015990 ()
14-U7581-160

  • Uric acid IVD, reagent

ALT R2 (w/ssa#) - 00811727013774

For the quantitative determination of Alanine Aminotransferase in serum.
POINTE SCIENTIFIC, INC.
13-A7526-R2-125
In Commercial Distribution

  • 00811727013774 ()
13-A7526-R2-125

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

ALT R1 (w/ssa#) - 00811727013767

For the quantitative determination of Alanine Aminotransferase in serum.
POINTE SCIENTIFIC, INC.
13-A7526-R1-500
In Commercial Distribution

  • 00811727013767 ()
13-A7526-R1-500

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

ALT R1 (w/ssa#) - 00811727013750

For the quantitative determination of Alanine Aminotransferase in serum.
POINTE SCIENTIFIC, INC.
13-A7526-R1-120
In Commercial Distribution

  • 00811727013750 ()
13-A7526-R1-120

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

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

Albumin (w/ssa#) - 00811727013699

For the quantitative determination of Albumin in serum.
POINTE SCIENTIFIC, INC.
13-A7502-500
In Commercial Distribution

  • 00811727013699 ()
13-A7502-500

  • Albumin IVD, kit, spectrophotometry

Albumin (w/ssa#) - 00811727013682

For the quantitative determination of Albumin in serum.
POINTE SCIENTIFIC, INC.
13-A7502-120
In Commercial Distribution

  • 00811727013682 ()
13-A7502-120

  • Albumin IVD, kit, spectrophotometry

Uric Acid - 00811727013675

For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
12-U7581-120
In Commercial Distribution

  • 00811727013675 ()
12-U7581-120

  • Uric acid IVD, reagent

Pointe Scientific, Inc. - 00811727012791

Uric Acid Reagent, for the quantitative determination of uric acid in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 5 x 100mL, 5 x 23mL
POINTE SCIENTIFIC, INC.
HU982-615
In Commercial Distribution

  • 00811727012791 ()
HU982-615

  • Uric acid IVD, reagent

Pointe Scientific, Inc. - 00811727012197

Uric Acid Standard intended for use as an uric acid standard for standardization or calibration of uricase / trinder uric acid procedures. Packaged at 1 x 15ml
POINTE SCIENTIFIC, INC.
U7580-STD
In Commercial Distribution

  • 00811727012197 ()
U7580-STD

  • Uric acid IVD, reagent

Pointe Scientific, Inc. - 00811727012180

Uric Acid Liquid Reagent Set for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Packaged at 1 x 1L
POINTE SCIENTIFIC, INC.
U7581-1L
In Commercial Distribution

  • 00811727012180 ()
U7581-1L

  • Uric acid IVD, reagent

Pointe Scientific, Inc. - 00811727012173

Uric Acid Liquid Reagent Set for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Packaged at 1 x 500ml
POINTE SCIENTIFIC, INC.
U7581-500
In Commercial Distribution

  • 00811727012173 ()
U7581-500

  • Uric acid IVD, reagent

Pointe Scientific, Inc. - 00811727012166

Uric Acid Liquid Reagent Set for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Packaged at 1 x 120ml
POINTE SCIENTIFIC, INC.
U7581-120
In Commercial Distribution

  • 00811727012166 ()
U7581-120

  • Uric acid IVD, reagent

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)

ACTS (5GL/20L RP) - 00810929014800

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-37
In Commercial Distribution

  • 00810929014800 ()


  • Medical device cleaning agent

ACTS (4.2oz/125ml with Dropper) - 00810929014787

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-07
In Commercial Distribution

  • 00810929014879 ()
  • 00810929014787 ()


  • Medical device cleaning agent

ALKAZIME (8.45oz/250ml bottle) - 00810929012196

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
13007-10
In Commercial Distribution

  • 10810929012193 ()
  • 00810929012196 ()


  • Medical device cleaning agent

ALKAZIME (1 Liter bottle) - 00810929012158

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
13007-22
In Commercial Distribution

  • 10810929012155 ()
  • 00810929012158 ()


  • Medical device cleaning agent

ACTS (8.45oz/250ml with Dropper) - 00810929010543

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-13
In Commercial Distribution

  • 00810929010550 ()
  • 00810929010543 ()


  • Medical device cleaning agent

ACTS (16.9oz/500ml with sprayer) - 00810929010338

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-16
In Commercial Distribution

  • 00810929010345 ()
  • 00810929010338 ()


  • Medical device cleaning agent

CARDINAL HEALTH - 10198956119680

KIT, PATIENT ADMISSIONS
Cardinal Health 200, LLC
AMNMI42159
In Commercial Distribution

  • 50198956119688 ()
  • 10198956119680 ()
AMNMI42159

  • General surgical procedure kit, non-medicated, single-use

ACRY-PEEL H2O (4.2oz/125ml with mister) - 00810929045118

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
54317-09
In Commercial Distribution

  • 10810929045115 ()
  • 00810929045118 ()


  • Medical device cleaning agent

ACTS (5GL/20L SP) - 00810929043992

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-36
In Commercial Distribution

  • 00810929043992 ()


  • Medical device cleaning agent
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