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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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1q21.3 Orange - 00847627000453

No Description
BIOCARE MEDICAL LLC
HFA7308A
In Commercial Distribution

  • 00847627000453 ()


  • Nucleic acid hybridization detection IVD, probe

1p21.2 Green - 00847627000446

No Description
BIOCARE MEDICAL LLC
HFA7307A
In Commercial Distribution

  • 00847627000446 ()


  • Nucleic acid hybridization detection IVD, probe

TP53 (17p13) Orange - 00847627000439

No Description
BIOCARE MEDICAL LLC
HFA7306A
In Commercial Distribution

  • 00847627000439 ()


  • Nucleic acid hybridization detection IVD, probe

RB1 (13q14.2) Orange - 00847627000422

No Description
BIOCARE MEDICAL LLC
HFA7298A
In Commercial Distribution

  • 00847627000422 ()


  • Nucleic acid hybridization detection IVD, probe

MYB (6q23) Orange - 00847627000415

No Description
BIOCARE MEDICAL LLC
HFA7283A
In Commercial Distribution

  • 00847627000415 ()


  • Nucleic acid hybridization detection IVD, probe

LAMP1 (13q34) Aqua - 00847627000408

No Description
BIOCARE MEDICAL LLC
HFA7282A
In Commercial Distribution

  • 00847627000408 ()


  • Nucleic acid hybridization detection IVD, probe

LAMP1 (13q34) Green - 00847627000392

No Description
BIOCARE MEDICAL LLC
HFA7281A
In Commercial Distribution

  • 00847627000392 ()


  • Nucleic acid hybridization detection IVD, probe

IGH (14q32) Variable Green - 00847627000385

No Description
BIOCARE MEDICAL LLC
HFA7279A
In Commercial Distribution

  • 00847627000385 ()


  • Nucleic acid hybridization detection IVD, probe

IGH (14q32) Constant Orange - 00847627000378

No Description
BIOCARE MEDICAL LLC
HFA7278A
In Commercial Distribution

  • 00847627000378 ()


  • Nucleic acid hybridization detection IVD, probe

FGFR3 (4p16.3) Orange - 00847627000361

No Description
BIOCARE MEDICAL LLC
HFA7277A
In Commercial Distribution

  • 00847627000361 ()


  • Nucleic acid hybridization detection IVD, probe

FGFR3 (4p16.3) Aqua - 00847627000354

No Description
BIOCARE MEDICAL LLC
HFA7276A
In Commercial Distribution

  • 00847627000354 ()


  • Nucleic acid hybridization detection IVD, probe

D13S319 (13q14.2) Orange - 00847627000347

No Description
BIOCARE MEDICAL LLC
HFA7267A
In Commercial Distribution

  • 00847627000347 ()


  • Nucleic acid hybridization detection IVD, probe

D13S25 (13q14.3) Orange - 00847627000330

No Description
BIOCARE MEDICAL LLC
HFA7266A
In Commercial Distribution

  • 00847627000330 ()


  • Nucleic acid hybridization detection IVD, probe

ATM (11q22.3) Orange - 00847627000323

No Description
BIOCARE MEDICAL LLC
HFA7262A
In Commercial Distribution

  • 00847627000323 ()


  • Nucleic acid hybridization detection IVD, probe

CCND1 (11q13) Orange - 00847627000316

No Description
BIOCARE MEDICAL LLC
HFA7260A
In Commercial Distribution

  • 00847627000316 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 17 Aqua - 00847627000309

No Description
BIOCARE MEDICAL LLC
HFA7226A
In Commercial Distribution

  • 00847627000309 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 17 Green - 00847627000293

No Description
BIOCARE MEDICAL LLC
HFA7225A
In Commercial Distribution

  • 00847627000293 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 12 Aqua - 00847627000286

No Description
BIOCARE MEDICAL LLC
HFA7211A
In Commercial Distribution

  • 00847627000286 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 12 Green - 00847627000279

No Description
BIOCARE MEDICAL LLC
HFA7210A
In Commercial Distribution

  • 00847627000279 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 10 Green - 00847627000262

No Description
BIOCARE MEDICAL LLC
HFA7200A
In Commercial Distribution

  • 00847627000262 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 4q12 Aqua - 00847627000255

No Description
BIOCARE MEDICAL LLC
HFA7169A
In Commercial Distribution

  • 00847627000255 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 4q12 Green - 00847627000248

No Description
BIOCARE MEDICAL LLC
HFA7168A
In Commercial Distribution

  • 00847627000248 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 3 Aqua - 00847627000231

No Description
BIOCARE MEDICAL LLC
HFA7164A
In Commercial Distribution

  • 00847627000231 ()


  • Nucleic acid hybridization detection IVD, probe

5p15.2 Red - 00847627000224

No Description
BIOCARE MEDICAL LLC
CFA7251X
In Commercial Distribution

  • 00847627000224 ()


  • Nucleic acid hybridization detection IVD, probe

5p15.2 Red - 00847627000217

No Description
BIOCARE MEDICAL LLC
CFA7251A
In Commercial Distribution

  • 00847627000217 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 10 Green - 00847627000200

No Description
BIOCARE MEDICAL LLC
CFA7200A
In Commercial Distribution

  • 00847627000200 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 7 Gold - 00847627000194

No Description
BIOCARE MEDICAL LLC
CFA7188Y
In Commercial Distribution

  • 00847627000194 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 7 Orange - 00847627000187

No Description
BIOCARE MEDICAL LLC
CFA7187A
In Commercial Distribution

  • 00847627000187 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 3 Aqua - 00847627000170

No Description
BIOCARE MEDICAL LLC
CFA7164Y
In Commercial Distribution

  • 00847627000170 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 3 Aqua - 00847627000163

No Description
BIOCARE MEDICAL LLC
CFA7164A
In Commercial Distribution

  • 00847627000163 ()


  • Nucleic acid hybridization detection IVD, probe

ImmunoFA Toxoplasma Slides - 00613745012070

For use with ImmunoFA Toxoplasma kits
Genbio
800-1207
In Commercial Distribution

  • 00613745012070 ()

  • 100 slides, 10 tests per slide
1207

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) - 05055273219180

The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total), Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin, Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids, Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen (CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose, Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a), Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin, Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC, Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12, Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LAL10625
In Commercial Distribution

  • 05055273219180 ()
LAL10625

  • Multiple-type clinical chemistry analyte profile IVD, control

AMH CONTROL LEVEL 3 (AMH CONTROL 3) - 05055273217797

The AMH Control Level 3 (AMH10515) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 3 (AMH10515) is assayed with target values and is suitable for use on automated analysers. The AMH Control Level 3 (AMH10515) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
AMH10515
In Commercial Distribution

  • 05055273217797 ()
AMH10515

  • Anti-Mullerian hormone (AMH) IVD, control

AMH CONTROL LEVEL 2 (AMH CONTROL 2) - 05055273217780

The AMH Control Level 2 (AMH10514) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 2 (AMH10514) is assayed with target values and is suitable for use on automated analysers. The AMH Control Level 2 (AMH10514) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
AMH10514
In Commercial Distribution

  • 05055273217780 ()
AMH10514

  • Anti-Mullerian hormone (AMH) IVD, control

AMH CONTROL LEVEL 1 (AMH CONTROL 1) - 05055273217773

The AMH Control Level 1 (AMH10509) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 1 (AMH10509) is assayed with target values and is suitable for use on automated analysers. The AMH Control Level 1 (AMH10509) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
AMH10509
In Commercial Distribution

  • 05055273217773 ()
AMH10509

  • Anti-Mullerian hormone (AMH) IVD, control

AMH CONTROL LEVEL 4 (AMH CONTROL 4) - 05055273217766

The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 4 (AMH10516) is assayed with target values and is suitable for use on automated analysers. The AMH Control Level 4 (AMH10516) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
AMH10516
In Commercial Distribution

  • 05055273217766 ()
AMH10516

  • Anti-Mullerian hormone (AMH) IVD, control

CARDIAC CONTROL - LEVEL 3 (CRD CONTROL 3) - 05055273217674

This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10431
In Commercial Distribution

  • 05055273217674 ()
CQ10431

  • Multiple cardiac marker IVD, control

CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2) - 05055273217667

This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10430
In Commercial Distribution

  • 05055273217667 ()
CQ10430

  • Multiple cardiac marker IVD, control

CARDIAC CONTROL - LEVEL 1 (CRD CONTROL 1) - 05055273217650

This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10429
In Commercial Distribution

  • 05055273217650 ()
CQ10429

  • Multiple cardiac marker IVD, control

CARDIAC ULTRA LOW CONTROL (CRD CONTROL Ultra Low) - 05055273217346

This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10428
In Commercial Distribution

  • 05055273217346 ()
CQ10428

  • Multiple cardiac marker IVD, control

LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2) - 05055273216837

Intended for in vitro diagnostic (IVD) use as a quality control material for determination of Total Bilirubin and Direct Bilirubin on chemistry analysers. For use in a clinical laboratory setting by trained personnel.
RANDOX LABORATORIES LIMITED
BR10443
In Commercial Distribution

  • 05055273216837 ()
BR10443

  • Total bilirubin IVD, control

LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1) - 05055273216820

Intended for in vitro diagnostic (IVD) use as a quality control material for determination of Total Bilirubin and Direct Bilirubin on chemistry analysers. For use in a clinical laboratory setting by trained personnel.
RANDOX LABORATORIES LIMITED
BR10442
In Commercial Distribution

  • 05055273216820 ()
BR10442

  • Total bilirubin IVD, control

CLINICAL CHEMISTRY LINEARITY VERIFIERS (For Roche Systems) - 05055273216684

Clinical Chemistry Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Albumin, BUN, Calcium, Total Cholesterol, Creatinine, Glucose, Lactate, Lithium, Magnesium, Phosphate, Total Protein, Triglycerides, Uric acid, Iron, Sodium, Potassium and Chloride assays.
RANDOX LABORATORIES LIMITED
LV10390
In Commercial Distribution

  • 05055273216684 ()
LV10390

  • Multiple-type clinical chemistry analyte profile IVD, control

LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC) - 05055273216455

Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for HDL, LDL and Triglycerides.
RANDOX LABORATORIES LIMITED
LV10364
In Commercial Distribution

  • 05055273216455 ()
LV10364

  • Multiple lipid analyte IVD, control

APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) - 05055273216448

Apolipoprotein A1 & B Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for Apolipoprotein A1 and Apolipoprotein B.
RANDOX LABORATORIES LIMITED
LV10363
In Commercial Distribution

  • 05055273216448 ()
LV10363

  • Multiple apolipoprotein IVD, control

APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R) - 05055273216271

Apo Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Apo A1 and Apo B.
RANDOX LABORATORIES LIMITED
LV10357
In Commercial Distribution

  • 05055273216271 ()
LV10357

  • Multiple apolipoprotein IVD, control

THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) - 05055273216264

Therapeutic Drug Markers (TDM) Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid and Vancomycin assays.
RANDOX LABORATORIES LIMITED
LV10355
In Commercial Distribution

  • 05055273216264 ()
LV10355

  • Multiple therapeutic drugs/drugs of abuse IVD, control

LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R) - 05055273216257

Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Cholesterol, HDL, LDL and Triglycerides.
RANDOX LABORATORIES LIMITED
LV10344
In Commercial Distribution

  • 05055273216257 ()
LV10344

  • Multiple lipid analyte IVD, control

LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 2 (LIQ CHEM ASY PREMIUM PL - 05055273214536

This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy.
RANDOX LABORATORIES LIMITED
LAN4214
In Commercial Distribution

  • 05055273214536 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) - 05055273210125

The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH Vitamin D,17-OH-Progesterone, Alpha-fetoprotein (AFP), Aldosterone, Androstenedione, Beta-2-Microglobulin (B-2M), CA125, CA15-3, CA19-9, Carbamazepine, Carcinoembryonic Antigen (CEA), Cortisol, DHEA-Sulphate, Digoxin, Ferritin, Folate, FSH, Gentamicin, Growth Hormone (GH), Total Beta hCG, Homocysteine, IGF-1, Immunoglobulin E (IgE), Insulin, Luteinizing Hormone, NT-Pro BNP, Oestradiol, Paracetamol, Phenobarbital, Phenytoin, Progesterone, Prolactin, PSA Free, PSA Total, Sex Hormone Binding Globulin (SHBG), Anti TPO, T Uptake, Free T3, Total T3, Free T4 Total T4, Testosterone, Theophylline, Tobramycin, Thyroglobulin, Thyroid Stimulating Hormone (TSH), Troponin I, Troponin T, Valproic Acid, Vancomycin and Vitamin B12. The device is unassayed without target values and is suitable for use on both Immunoassay and Clinical Chemistry analysers. Liquid Immunoassay Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LIA5144
In Commercial Distribution

  • 05055273210125 ()
LIA5144

  • Multiple-type clinical chemistry analyte profile IVD, control
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