Primary Device ID | 05391516741873 |
NIH Device Record Key | abb6d403-dac6-47ee-9cd3-ee750f221d99 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Trinity Biotech |
Version Model Number | 450-1-50 |
Catalog Number | 450-1-50 |
Company DUNS | 988298840 |
Company Name | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +35312769800 |
Clinicalchemistry.techsupport@ |
Total Volume | 50 Milliliter |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05391516741873 [Primary] |
KWW | Radioimmunoassay, Cholyglycine, Bile Acids |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-23 |
05391516749640 | Oxalate Sample Diluent |
05391516749411 | G-6-PDH Substrate 5x10 |
05391516746014 | ACE Reagent |
05391516745680 | Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (50 Tests) |
05391516743228 | Red Cell Lysing Reagent (4 x 25mL) |
05391516743204 | Oxalate Urine Control - N |
05391516743198 | Oxalate Urine Control - E |
05391516742290 | Lactate Standard (40 mg/dl) |
05391516742245 | Oxalate Kit |
05391516742238 | Oxalate Kit |
05391516742221 | Oxalate Sample Diluent |
05391516742214 | Oxalate Standards 0.50 MMOL/L |
05391516742207 | Sample Purifier Tubes |
05391516742191 | Oxalate Reagent B |
05391516742184 | Oxalate Standards |
05391516742177 | Sample Purifier Tubes |
05391516742160 | Oxalate Reagent A |
05391516741927 | Bile Acids Kit |
05391516741910 | Bile Acids Stop Reagent |
05391516741903 | Bile Acids Reagent B (25 mL) |
05391516741897 | Bile Acids Controls |
05391516741880 | Bile Acids Reagent B (5 mL) |
05391516741873 | Bile Acids Reagent A (50 mL) |
05391516741866 | Bile Acid Calibrator Set (5 x 5 mL) |
05391516741859 | Bile Acid Calibrator 100 umol/l (5 mL) |
05391516741712 | G-6-PDH Deficiency 100X Kit |
05391516741705 | G-6-PDH Deficiency 5 x 20 Kit |
05391516741699 | Mineral Oil |
05391516741682 | Mineral Oil |
05391516741675 | Trizma Buffer Solution |
05391516741651 | G-6-PDH Substrate 10x10 |
05391516741552 | Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (20 Tests) |
05391516741521 | G-6-PDH Deficiency (50 Tests) |