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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CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-01
In Commercial Distribution

  • 00380740017088 ()
08H5801

  • Full blood count IVD, control
CELL-DYN HemCal Plus Calibrator
ABBOTT LABORATORIES
08H57-01
In Commercial Distribution

  • 00380740017071 ()
08H5701

  • Full blood count IVD, calibrator
Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.
PROMEGA CORPORATION
MD2140
In Commercial Distribution

  • 00849811031717 ()
MD2140

  • Microsatellite instability IVD, kit, nucleic acid technique (NAT)
VERSANT® Tissue Preparation Reagents (Box 3)
Siemens Healthcare Diagnostics Inc.
10632400
Not in Commercial Distribution

  • 00630414588810 ()
10632400

  • Nucleic acid extraction/isolation kit IVD
Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
292X
In Commercial Distribution

  • 00847661004301 ()
292X

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
293
In Commercial Distribution

  • 00847661004295 ()
293

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
292
In Commercial Distribution

  • 00847661004288 ()
292

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
291
In Commercial Distribution

  • 00847661004271 ()
291

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
172X
In Commercial Distribution

  • 00847661002192 ()
172X

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
173
In Commercial Distribution

  • 00847661000853 ()
173

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
172
In Commercial Distribution

  • 00847661000846 ()
172

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
171
In Commercial Distribution

  • 00847661000839 ()
171

  • Glycated haemoglobin (HbA1c) IVD, control
Lumipulse G B-Amyloid Controls (Plasma)-N
FUJIREBIO INC.
235485
Not in Commercial Distribution

  • 04987270235485 ()

  • 4 bottles per unit; 1.0mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
Lumipulse G B-Amyloid 1-42-N Plasma IRC
FUJIREBIO INC.
235447
In Commercial Distribution

  • 04987270235447 ()

  • 42 Tests per Kit


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
UF ll CALIBRATOR
SYSMEX CORPORATION
06404310
In Commercial Distribution

  • 04987562408535 ()
  • 84987562408531 ()


  • Urine sediment IVD, calibrator
UF-CONTROL contains control particles for use in quality control measurement procedure of the Sysmex Fully Automated Urine Particle Analyzers and the Sysmex Fully Automated Urine Particle Digital Imaging Device.
SYSMEX CORPORATION
06404115
In Commercial Distribution

  • 04987562408528 ()

  • Total Volume: 47 Milliliter


  • Buffered sample diluent IVD
Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
73806
In Commercial Distribution

  • 04987486738060 ()


  • Multiple urine analyte IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-06201
In Commercial Distribution

  • 04987481164673 ()
991-06201

  • Albumin IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-06001
In Commercial Distribution

  • 04987481164666 ()
999-06001

  • Albumin IVD, kit, nephelometry/turbidimetry
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-43701
In Commercial Distribution

  • 04987481164659 ()
991-43701

  • Total complement activity (CH50) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-76491
In Commercial Distribution

  • 04987481164642 ()
997-76491

  • Non-esterified fatty acid IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-06101
In Commercial Distribution

995-06101

  • Microalbumin IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-61201
In Commercial Distribution

999-61201

  • Des-gamma-carboxyprothrombin (DCP) IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-60901
In Commercial Distribution

997-60901

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-60701
In Commercial Distribution

995-60701

  • Des-gamma-carboxyprothrombin (DCP) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-40801
In Commercial Distribution

995-40801

  • Total complement activity (CH50) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-60601
In Commercial Distribution

999-60601

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, reagent
Drug 3 Calibrator- Level A - 6x2mL, Level B 3x1.5ml, Level C 3X1.5 mL
Siemens Healthcare Diagnostics Inc.
10285194
Not in Commercial Distribution

  • 00842768025211 ()
KC430A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Beckman Coulter, Inc.
33211
In Commercial Distribution

  • H628332111 ()
33211

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
20766399122
In Commercial Distribution

  • 04015630915644 ()
20766399122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
No Description
Roche Diagnostics GmbH
20766305122
In Commercial Distribution

  • 04015630915637 ()
20766305122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
No Description
Vista Dental
803801-16
In Commercial Distribution

  • 10818207024418 ()


  • Root canal cleaning solution
No Description
Vista Dental
803802-16
In Commercial Distribution

  • 10818207024401 ()


  • Root canal cleaning solution
No Description
Vista Dental
6000000
In Commercial Distribution

  • 10818207024388 ()


  • Endodontic lavage system
No Description
Vista Dental
6000001
In Commercial Distribution

  • 10818207024371 ()


  • Endodontic lavage system
No Description
Vista Dental
6000002
In Commercial Distribution

  • 10818207024364 ()


  • Endodontic lavage system
No Description
Vista Dental
803803-16
In Commercial Distribution

  • 10818207024357 ()


  • Root canal cleaning solution
KIT, OPTIGEN US Environmental 36 (40ND)
Minaris Medical America, Inc.
85168
In Commercial Distribution

  • 00813382012178 ()
85168

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 30 (40ND)
Minaris Medical America, Inc.
85167
In Commercial Distribution

  • 00813382012154 ()
85167

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 25
Minaris Medical America, Inc.
85066
In Commercial Distribution

  • 00813382010440 ()
85066

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 25 (100 ND)
Minaris Medical America, Inc.
85082
In Commercial Distribution

  • 00813382010433 ()
85082

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Inhalant 36 (100 ND)
Minaris Medical America, Inc.
85081
In Commercial Distribution

  • 00813382010426 ()
85081

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Panel Control Reagent
Minaris Medical America, Inc.
80109
In Commercial Distribution

  • 00813382010402 ()
80109

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
KIT, OPTIGEN US Mix 36
Minaris Medical America, Inc.
85065
In Commercial Distribution

  • 00813382010396 ()
85065

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 20
Minaris Medical America, Inc.
85064
In Commercial Distribution

  • 00813382010389 ()
85064

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Inhalant 36
Minaris Medical America, Inc.
85063
In Commercial Distribution

  • 00813382010372 ()
85063

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
UP20 Negative Control Reagent
Minaris Medical America, Inc.
80108
Not in Commercial Distribution

  • 00813382010358 ()
  • 00813382010365 ()
80108

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
Kit, Southern
Minaris Medical America, Inc.
84508
Not in Commercial Distribution

  • 00813382010334 ()
84508

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
UP20 Positive Control Reagent
Minaris Medical America, Inc.
80107
Not in Commercial Distribution

  • 00813382010280 ()
  • 00813382010341 ()
80107

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
CLA Pos Ctrl Serum
Minaris Medical America, Inc.
93026
In Commercial Distribution

  • 00813382010198 ()
  • 00813382010303 ()
93026

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
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