No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 14560189212463 | N/A | LCP | Assay, Glycosylated Hemoglobin | ST AIA-PACK HbA1c | |||
2 | 14560189212135 | N/A | KHQ | Radioassay, Triiodothyronine Uptake | ST AIA-PACK T-U | |||
3 | 14560189212005 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK RBC FOLATE | |||
4 | 04560189211827 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | AIA-PACK PRL CALIBRATOR SET | ||
5 | 04560189211407 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI CALIBRATOR SET | ||
6 | 04560189211292 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Sample Diluting Solution | ||
7 | 04560189212299 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK bHCG Calibration Verification Test Set | ||
8 | 04560189212022 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK RBC FOLATE HEMOLYZING REAGENT SET | ||
9 | 14560189212739 | N/A | CHP | Radioimmunoassay, Estradiol | ST AIA-PACK hsE2 | |||
10 | 14560189212517 | N/A | CKG | Radioimmunoassay, Acth | ST AIA-PACK ACTH | |||
11 | 14560189212104 | n/a | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | ST AIA-PACK PA | |||
12 | 14560189211916 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK Folate | |||
13 | 04560189211940 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK Floate Sample Diluting Solution | ||
14 | 14560189211879 | N/A | CDD | Radioassay, Vitamin B12 | AIA-PACK B12 | |||
15 | 04560189211889 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Calibrator Set | ||
16 | 04560189211650 | N/A | CEP | Radioimmunoassay, Luteinizing Hormone | 1 | ST AIA-PACK LH II CALIBRATOR SET | ||
17 | 04560189211445 | N/A | CFL | Radioimmunoassay, Human Growth Hormone | 1 | AIA-PACK HGH Calibrator Set | ||
18 | 04560189211391 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI SAMPLE DILUTING SOLUTION | ||
19 | 04560189211308 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Calibrator Set | ||
20 | 14560189210834 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | ST AIA-PACK PRL | |||
21 | 14560189210483 | N/A | DBF | Ferritin, Antigen, Antiserum, Control | ST AIA-PACK FER | |||
22 | 14560189210391 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | ST AIA-PACK FSH | |||
23 | 14560189210360 | N/A | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | ST AIA-PACK TSH | ||
24 | 14560189210285 | N/A | CDP | Radioimmunoassay, Total Triiodothyronine | ST AIA-PACK FT3 | |||
25 | 14560189210117 | N/A | MMI | Immunoassay Method, Troponin Subunit | ST AIA-PACK cTnI 2 | |||
26 | 04560189212817 | N/A | LPS | Urinary Homocystine (Nonquantitative) Test System | 2 | ST AIA-PACK Homocysteine Pretreatment Set | ||
27 | 04560189212800 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK Homocysteine Control Set | ||
28 | 04560189212596 | N/A | JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | ST AIA-PACK DHEA-S Sample Diluting Solution | ||
29 | 04560189212190 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Cystatin C Calibatator Set | ||
30 | 04560189211285 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | ST AIA-PACK E2 CALIBRATOR SET | ||
31 | 04560189211278 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | AIA-PACK E2 Sample Diluting Solution | ||
32 | 04560189211148 | N/A | LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | AIA-PACK CA 125 Calibrator Set | ||
33 | 04560189211124 | N/A | NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pa System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 2 | AIA-PACK CA 19-9 Sample Diluting Solution | ||
34 | 04560189211100 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | 2 | AIA-PACK 27.29 Calibrator Set | ||
35 | 14560189212173 | N/A | NDY | Test, Cystatin C | ST AIA-PACK Cystatin C | |||
36 | 04560189211902 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Sample Diluting Solution | ||
37 | 04560189211780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | 2 | AIA-PACK CEA Sample Diluting Solution | ||
38 | 04560189211421 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Intact PTH CALIBRATOR SET | ||
39 | 04560189211414 | N/A | CEW | Radioimmunoassay, Parathyroid Hormone | 2 | ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION | ||
40 | 04560189211353 | N/A | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | AIA-PACK βHCG Calibrator Set | ||
41 | 14560189210780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | ST AIA-PACK CEA | |||
42 | 14560189213125 | N/A | MRG | System, Test, Vitamin D | ST AIA-PACK 25-OH Vitamin D | |||
43 | 14560189210179 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | ST AIA-PACK 27.29 | |||
44 | 14560189210155 | N/A | DGC | Ige, Antigen, Antiserum, Control | ST AIA-PACK IgEII | |||
45 | 04560189284005 | N/A | KHO | Fluorometer, For Clinical Use | 1 | 9tray Sorter | ||
46 | 04560189283992 | AIA-900 | KHO | Fluorometer, For Clinical Use | 1 | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 | ||
47 | 04560189283619 | N/A | LCP | Assay, Glycosylated Hemoglobin | 2 | G8 Variant Elution Buffer HSi No.2 (S) | ||
48 | 04560189213395 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK PROG II CALIBRATOR SET | ||
49 | 04560189213371 | N/A | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | ||
50 | 04560189213333 | N/A | JIT | Calibrator, Secondary | 2 | AIA-PACK C-Peptide II Calibrator Set |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07613336157824 | 08445699190 | 08445699190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
2 | 07613336140680 | 08105677190 | 08105677190 | Fructosamine | ROCHE DIAGNOSTICS GMBH | |
3 | 07613336120927 | 08056668190 | 08056668190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
4 | 07070060005683 | 1115015 | 1115015 | Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in hu Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 Test Cartridges. 1 Package Insert. DI covers Alere Afinion HbA1c and Afinion HbA1c. | Alere Afinion™ HbA1c | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
5 | 05391516749473 | Tri-stat 2 Analyzer | 03-06-0002 | Tri-stat 2 Analyzer | Trinity Biotech | PRIMUS CORPORATION |
6 | 05391516748636 | PDQ Wash Reagent | 01-03-0067 | Hemoglobin A1c assay, PDQ Wash Reagent | Trinity Biotech | PRIMUS CORPORATION |
7 | 05391516748629 | PDQ Diluent Reagent - 940mL | 01-03-0066 | Hemoglobin A1c assay, PDQ Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
8 | 05391516748612 | PDQ 2 Reagent - 940mL | 01-03-0065 | Hemoglobin A1c assay, PDQ 2 Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
9 | 05391516748605 | PDQ1 Reagent - 940mL | 01-03-0064 | Hemoglobin A1c assay, PDQ1 Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
10 | 05391516748223 | Tri-stat Reagent Kit | 03-06-0010 | Hemoglobin A1c assay, Tri-stat Reagent Kit | Trinity Biotech | PRIMUS CORPORATION |
11 | 05391516748162 | Ultra2 Affinity A1c 3000 | 01-04-0080 | Hemoglobin A1c assay, Ultra2 Affinity A1c 3000 | Trinity Biotech | PRIMUS CORPORATION |
12 | 05391516748155 | Ultra2 Affinity HbA1c Analyzer (110V) | 03-01-0052 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (110V) | Trinity Biotech | PRIMUS CORPORATION |
13 | 05391516748148 | Premier Affinity A1c 3000 - 1 kit | 09-03-0007 | Hemoglobin A1c assay, Premier Affinity A1c 3000 - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
14 | 05391516748131 | Premier Affinity A1c 1000 - 1 kit | 09-03-0010 | Hemoglobin A1c assay, Premier Affinity A1c 1000 - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
15 | 05391516748124 | Premier Affinity A1c 500 - 1 kit | 09-03-0008 | Hemoglobin A1c assay, Premier Affinity A1c 500 - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
16 | 05391516748117 | Premier Sample Diluent Reagent - 940mL | 01-03-0101 | Hemoglobin A1c assay, Premier Sample Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
17 | 05391516748100 | Premier Buffer B Reagent - 3.8L | 01-03-0081 | Hemoglobin A1c assay, Premier Buffer B Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
18 | 05391516748094 | Premier Buffer A Reagent - 3.8L | 01-03-0080 | Hemoglobin A1c assay, Premier Buffer A Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
19 | 05391516748063 | Premier Hb9210 HbA1c Analytical Column (500) | 09-06-0050 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (500) | Trinity Biotech | PRIMUS CORPORATION |
20 | 05391516748056 | Premier Hb9210 HbA1c Analytical Column (1000) | 09-06-0046 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (1000) | Trinity Biotech | PRIMUS CORPORATION |
21 | 05391516744799 | Premier Wash Reagent - 940mL | 01-03-0098 | Hemoglobin A1c assay, Premier Wash Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
22 | 05391516744782 | Premier Diluent Reagent - 3.8L | 01-03-0097 | Hemoglobin A1c assay, Premier Diluent Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
23 | 05391516744775 | Premier Buffer B Reagent - 940mL | 01-03-0096 | Hemoglobin A1c assay, Premier Buffer B Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
24 | 05391516744768 | Premier Buffer A Reagent - 940mL | 01-03-0095 | Hemoglobin A1c assay, Premier Buffer A Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
25 | 05391516744751 | Premier Hb9210 HbA1c Analyzer - 1 each | 09-00-0001 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analyzer | Trinity Biotech | PRIMUS CORPORATION |
26 | 05391516744553 | Affinity Analytical Column | 03-02-0079 | Hemoglobin A1c assay, Affinity Analytical Column | Trinity Biotech | PRIMUS CORPORATION |
27 | 05391516744546 | Enzyme Cleaner Tube | 01-12-0001 | Hemoglobin A1c assay, Enzyme Cleaner Tube | Trinity Biotech | PRIMUS CORPORATION |
28 | 05391516744317 | 2 Diluent Reagent - 940mL | 01-03-0059 | Hemoglobin A1c assay, 2 Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
29 | 05391516744294 | 2 Diluent Reagent - 3.8L | 01-03-0058 | Hemoglobin A1c assay, 2 Diluent Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
30 | 05391516744287 | Ultra2 Buffer 2A Reagent - 3.8L | 01-03-0054 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
31 | 05391516744270 | Ultra2 Buffer 2A Reagent - 940mL | 01-03-0053 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
32 | 05391516744218 | System Wash Reagent - 940mL | 01-03-0035 | Hemoglobin A1c assay, System Wash Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
33 | 05391516744171 | Ultra2 Buffer B Reagent - 3.8L | 01-03-0012 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
34 | 05391516744164 | Ultra2 Buffer B Reagent - 940mL | 01-03-0011 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
35 | 05391516744126 | Ultra2 Affinity HbA1c Analyzer (220V) | 03-01-0048 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (220V) | Trinity Biotech | PRIMUS CORPORATION |
36 | 05055273208856 | HA8321 | HA8321 | The product is intended for the quantitative in vitro determination of Haemoglob The product is intended for the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood. | HbA1C | RANDOX LABORATORIES LIMITED |
37 | 05055273208733 | FR4030 | FR4030 | FRUCTOSAMINE (FRUC) | RANDOX LABORATORIES LIMITED | |
38 | 05055273208726 | FR3133 | FR3133 | Enzymatic assay for the quantitative in vitro determination of glycated protein Enzymatic assay for the quantitative in vitro determination of glycated protein (fructosamine) in human serum or plasma. | FRUC | RANDOX LABORATORIES LIMITED |
39 | 05055273203561 | HA3830 | HA3830 | A Haemoglobin A1c test system is a device intended for the quantitative in vitro A Haemoglobin A1c test system is a device intended for the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood | HbA1C | RANDOX LABORATORIES LIMITED |
40 | 05055273203554 | HA3450 | HA3450 | HAEMOGLOBIN A1c (HbA1c) | RANDOX LABORATORIES LIMITED | |
41 | 05055273203530 | HA3444 | HA3444 | This product is intended for in vitro diagnostic use in the calibration of HbA1c This product is intended for in vitro diagnostic use in the calibration of HbA1c on clinical chemistry systems. | HbA1C CAL | RANDOX LABORATORIES LIMITED |
42 | 04987153301047 | L242GA | L242GA | ALB R-2 Coloring solution 20mL x 2 | Lucica® Glycated Albumin-L ALB R-2 | ASAHI KASEI PHARMA CORPORATION |
43 | 04987153301030 | L232GA | L232GA | ALB R-1 Pretreatment solution 40 mL x 2 | Lucica® Glycated Albumin-L ALB R-1 | ASAHI KASEI PHARMA CORPORATION |
44 | 04987153301023 | L222GA | L222GA | GA R-2 Enzymatic solution 10mL x 2 | Lucica® Glycated Albumin-L GA R-2 | ASAHI KASEI PHARMA CORPORATION |
45 | 04987153301016 | L212GA | L212GA | GA R-1 Pretreatment solution 40 mL x 2 | Lucica® Glycated Albumin-L GA R-1 | ASAHI KASEI PHARMA CORPORATION |
46 | 04560189283640 | N/A | Hemoglobin A1c Calibrator Set | TOSOH CORPORATION | ||
47 | 04560189283626 | N/A | G8 Variant Elution Buffer HSi No.3 (S) | TOSOH CORPORATION | ||
48 | 04560189283619 | N/A | G8 Variant Elution Buffer HSi No.2 (S) | TOSOH CORPORATION | ||
49 | 04560189283602 | N/A | G8 Variant Elution Buffer HSi No.1 (S) | TOSOH CORPORATION | ||
50 | 04560189283473 | N/A | G7 Variant Elution Buffer HSi No.3 (S) | TOSOH CORPORATION |