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DBM Paste
Rti Surgical, Inc.
007890
In Commercial Distribution
- 00854095006467 ()
007890
- Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
007875
In Commercial Distribution
- 00854095006450 ()
007875
- Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
007845
In Commercial Distribution
- 00854095006443 ()
007845
- Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
007830
In Commercial Distribution
- 00854095006436 ()
007830
- Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
007820
In Commercial Distribution
- 00854095006429 ()
007820
- Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
006820
In Commercial Distribution
- 00854095006412 ()
006820
- Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
006810
In Commercial Distribution
- 00854095006405 ()
006810
- Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
006805
In Commercial Distribution
- 00854095006399 ()
006805
- Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
005810
In Commercial Distribution
- 00854095006344 ()
005810
- Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
005805
In Commercial Distribution
- 00854095006337 ()
005805
- Bone matrix implant, human-derived
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
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
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
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
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
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
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
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
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
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 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 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 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
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 (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 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
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
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
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
Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT Cartridges
Curetis GmbH
M1 Master Mix Tube Kit
Not in Commercial Distribution
- 04260364750041 ()
10020
- DNA amplification enzyme reagent IVD
Fixture Φ3.2/L14.5
Achimhai Medical Corporation
I3215M-SH
In Commercial Distribution
- 08800024913797 ()
I3215M-SH
- Screw endosteal dental implant, two-piece
Fixture Φ3.2/L9.5
Achimhai Medical Corporation
I3210M-SH
In Commercial Distribution
- 08800024913766 ()
I3210M-SH
- Screw endosteal dental implant, two-piece
Fixture Φ3.2/L14.5
Achimhai Medical Corporation
I3215-SH
In Commercial Distribution
- 08800024913742 ()
I3215-SH
- Screw endosteal dental implant, two-piece
Fixture Φ3.2/L9.5
Achimhai Medical Corporation
I3210M
In Commercial Distribution
- 08800024913667 ()
I3210M
- Screw endosteal dental implant, two-piece
Fixture Φ3.2/L14.5
Achimhai Medical Corporation
I3215
In Commercial Distribution
- 08800024913643 ()
I3215
- Screw endosteal dental implant, two-piece
Fixture Φ3.2/L8.0
Achimhai Medical Corporation
I3208
In Commercial Distribution
- 08800024913605 ()
I3208
- Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L8.0
Achimhai Medical Corporation
MFX-3208S
In Commercial Distribution
- 08800024912592 ()
MFX-3208S-A
- Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L9.5
Achimhai Medical Corporation
MFX-3210S
In Commercial Distribution
- 08800024912585 ()
MFX-3210S-A
- Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L14.5
Achimhai Medical Corporation
MFX-3215S
In Commercial Distribution
- 08800024912554 ()
MFX-3215S-A
- Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L8.0
Achimhai Medical Corporation
MFX-3208SD
In Commercial Distribution
- 08800024912547 ()
MFX-3208SD-A
- Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L9.5
Achimhai Medical Corporation
MFX-3210SD
In Commercial Distribution
- 08800024912530 ()
MFX-3210SD-A
- Screw endosteal dental implant, two-piece