| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08806133010136 | FPRR028 | FPRR028 | FLUOROMETER FOR CLINICAL USE | ALFIS-3 | |||
| 2 | 08806133005279 | AFIAS TSH-VB | SMFP-58 | AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunof AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid indiciduals. | JLW,KHO | Radioimmunoassay, Thyroid-Stimulating Hormone,Fluorometer, For Clinical Use | AFIAS TSH-VB | |
| 3 | 08806133005255 | CFPO-15-1 | CFPO-15-1 | OOX | Automated Occult Blood Analyzer | AFIAS iFOB with AFIAS-50 | ||
| 4 | 08806133032008 | FPRR001 | FPRR001 | OOX | Automated Occult Blood Analyzer | 2 | ichroma Reader | |
| 5 | 08806133010242 | FPRR032 | JJH | Clinical Sample Concentrator | 1 | NuActor | ||
| 6 | 08806133010099 | FPRR001 | FPRR001 | DCN | System, Test, C-Reactive Protein | 2 | ichroma Reader | |
| 7 | 08806133005262 | AFIAS TSH-SP | SMFP-57 | AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunof AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in serum, sodium-heparinized plasma, or EDTA Plasma samples. | KHO,JLW | Fluorometer, For Clinical Use,Radioimmunoassay, Thyroid-Stimulating Hormone | AFIAS TSH-SP | |
| 8 | 08806679001520 | i-CHOMRA CRP-25 | i-CHOMRA CRP-25 | DCN | System, Test, C-Reactive Protein | ichroma™ CRP | ||
| 9 | 08806133010082 | FPRR020-5 | FPRR020-5 | AFIAS-6/VB Analyzer is a flurorescence-scanning for in vitro diagnostic use at c AFIAS-6/VB Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in venous whole blood samples.. | JLW,KHO | Radioimmunoassay, Thyroid-Stimulating Hormone,Fluorometer, For Clinical Use | 1 | AFIAS-6/VB Analyzer |
| 10 | 08806133060353 | AFIAS-TSHCLT | JLW,KHO | Radioimmunoassay, Thyroid-Stimulating Hormone,Fluorometer, For Clinical Use | 1 | Boditech TSH Control | ||
| 11 | 08806679002718 | CFPC-15 | CFPC-15 | OOX,JJX | Automated Occult Blood Analyzer,Single (Specified) Analyte Controls (Assayed And Automated Occult Blood Analyzer,Single (Specified) Analyte Controls (Assayed And Unassayed) | ichroma™ iFOB | ||
| 12 | 08806133080603 | UFPK-1 | UFPK-1 | NuActor Viral RNA Extraction kit | ||||
| 13 | 08806133010075 | FPRR020-4 | FPRR020-4 | AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at c AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in serum or plasma samples. | KHO,JLW | Fluorometer, For Clinical Use,Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | AFIAS-6/SP Analyzer |
| 14 | 08806133070437 | AFIAS-TSHCAL | KHO,JLW | Fluorometer, For Clinical Use,Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | Boditech TSH Calibrator |