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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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DBM Paste
Rti Surgical, Inc.
005801
In Commercial Distribution

  • 00854095006320 ()
005801

  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
005800
In Commercial Distribution

  • 00854095006313 ()
005800

  • Bone matrix implant, human-derived
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000259 ()
PSP-101

  • Tendon graft
Optiflow Nasal Filtered Interface with CO2 Sampling Medium
FISHER & PAYKEL HEALTHCARE LIMITED
AA031JM
In Commercial Distribution

  • 09420012470959 ()
  • 09420012470942 ()

  • MEDIUM
AA031JM

  • Nasal oxygen cannula, basic
Adult Optiflow Heated Circuit Kit
FISHER & PAYKEL HEALTHCARE LIMITED
950A40J
In Commercial Distribution

  • 09420012461223 ()
  • 09420012461117 ()
950A40J

  • Ventilator breathing circuit, single-use
The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays stated in this package insert.
RANDOX LABORATORIES LIMITED
LIA3108
In Commercial Distribution

  • 05055273207248 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
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
LAL4213
In Commercial Distribution

  • 05055273209006 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
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
LAE4215
In Commercial Distribution

  • 05055273208986 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
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
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
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