No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00875197005936 | 07972466190 | 07972466190 | cobas Zika (480 tests) | ||||
2 | 00365702398108 | 5530199160 | 5530199160 | GJS | TEST, TIME, PROTHROMBIN | 2 | CoaguChek XS Pro Kit | |
3 | 00075537180075 | 11379194160 | 11379194160 | KHE | REAGENT, OCCULT BLOOD | 2 | Calibration Strip (Urisys 1100, cobas u 411) | |
4 | 00075537018934 | 11893467160 | 11893467160 | CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | 1 | Chemstrip 5 OB Test Strips | |
5 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | MZF | Test, HIV detection | 2 | Elecsys HIV Duo |
6 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
7 | 07613336179512 | 09205683001 | 09205683001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro transport line | |
8 | 07613336179499 | 09205632001 | 09205632001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro SSU | |
9 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
10 | 07613336171677 | 09007784190 | 09007784190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
11 | 07613336171660 | 09007741190 | 09007741190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
12 | 07613336170212 | 08924180160 | 08924180160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
13 | 07613336170182 | 08924163160 | 08924163160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
14 | 07613336166949 | 08836973190 | 08836973190 | MZF | Test, HIV detection | 2 | Elecsys HIV Duo | |
15 | 07613336164884 | 08764760190 | 08764760190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
16 | 07613336159804 | 04985354160 | 04985354160 | Anti-HBs CC 3 Elecsys | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | Anti-HBs CalCheck |
17 | 07613336158784 | 08463662001 | 08463662001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas c 503 analytical unit | |
18 | 07613336155332 | 08372284001 | 08372284001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
19 | 07613336155318 | 08376824190 | 08376824190 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
20 | 07613336154403 | 03500373190 | 03500373190 | MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Ca Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | free PSA CalCheck | |
21 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
22 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
23 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
24 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
25 | 07613336153949 | 04927931161 | 04927931161 | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | PreciControl Anti-HBc II | |
26 | 07613336147672 | 08243875190 | 08243875190 | JIT | Calibrator, secondary | 2 | CalSet PTH | |
27 | 07613336141953 | 5920353001 | 5984840001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
28 | 07613336133644 | 08105596190 | 08105596190 | NDY | TEST, CYSTATIN C | 2 | Tina-quant Cystatin C Gen.2 | |
29 | 07613336133583 | 08105529190 | 08105529190 | JZG | System, test, beta-2-microglobulin immunological | 2 | Tinaquant ß2Microglobulin | |
30 | 07613336133521 | 08105448190 | 08105448190 | DER | ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Apolipoprotein A-1 ver.2 | |
31 | 07613336130230 | 08101396190 | 08101396190 | DEM | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant a1-Antitrypsin ver.2 | |
32 | 07613336121429 | 08058024190 | 08058024190 | JIF | ENZYMATIC METHOD, AMMONIA | 1 | Ammonia II | |
33 | 07613336121351 | 08057940190 | 08057940190 | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Lactate Gen.2 | |
34 | 07613336121238 | 08057648190 | 08057648190 | DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Ferritin Gen.4 | |
35 | 07613336121108 | 08057435190 | 08057435190 | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | ONLINE TDM Carbamazepine Gen.4 | |
36 | 07613336121061 | 08056951190 | 08056951190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Bilirubin Direct Gen.2 | |
37 | 04015630999477 | 5133181160 | 5133181160 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Elecsys Anti-CCP CalCheck | |
38 | 04015630995318 | 11776827160 | 11776827160 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Elecsys CalCheck FSH | |
39 | 04015630999200 | 4357221190 | 4357221190 | DLJ | CALIBRATORS, DRUG SPECIFIC | 2 | Total MPA Calibrators | |
40 | 04015630999149 | 4924495190 | 4924495190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
41 | 04015630997954 | 4642465190 | 4642465190 | LEG | ENZYME IMMUNOASSAY, VALPROIC ACID | 2 | Valproic Acid ONLINE TDM Valproic Acid | |
42 | 04015630997756 | 4490894190 | 4490894190 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
43 | 04015630996575 | 3304680190 | 3304680190 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Preciset DAT Plus II | |
44 | 04015630995202 | 11776614190 | 11776614190 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | AFP CalCheck | |
45 | 04015630994847 | 11815601216 | 11815601216 | LGI | FLUORESCENCE POLARIZATION IMMUNOASSAY, CARBAMAZEPINE | 2 | CEDIA Carbamazepine II | |
46 | 04015630994533 | 20766356122 | 20766356122 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | LSD CalibrationControl Pack | |
47 | 04015630993468 | 20737976122 | 20737976122 | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | Abuscreen OnLine Barbiturates | |
48 | 04015630993284 | 11986082216 | 11986082216 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
49 | 04015630991853 | 11876899216 | 11876899216 | CFR | HEXOKINASE, GLUCOSE | 2 | Glucoquant GlucoseHK | |
50 | 04015630991778 | 11868152190 | 11868152190 | DML | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD | 2 | Ethyl Alcohol ETH |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10304040080594 | 5701036 | 5701036 | Handheld portable analyzer for Lipid and Glucose Testing, Blood Sample used is 40ul | Henry Schein | HENRY SCHEIN, INC. |
2 | 07613336157824 | 08445699190 | 08445699190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
3 | 07613336140680 | 08105677190 | 08105677190 | Fructosamine | ROCHE DIAGNOSTICS GMBH | |
4 | 07613336120927 | 08056668190 | 08056668190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
5 | 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 |
6 | 05391516749473 | Tri-stat 2 Analyzer | 03-06-0002 | Tri-stat 2 Analyzer | Trinity Biotech | PRIMUS CORPORATION |
7 | 05391516748636 | PDQ Wash Reagent | 01-03-0067 | Hemoglobin A1c assay, PDQ Wash Reagent | Trinity Biotech | PRIMUS CORPORATION |
8 | 05391516748629 | PDQ Diluent Reagent - 940mL | 01-03-0066 | Hemoglobin A1c assay, PDQ Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
9 | 05391516748612 | PDQ 2 Reagent - 940mL | 01-03-0065 | Hemoglobin A1c assay, PDQ 2 Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
10 | 05391516748605 | PDQ1 Reagent - 940mL | 01-03-0064 | Hemoglobin A1c assay, PDQ1 Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
11 | 05391516748223 | Tri-stat Reagent Kit | 03-06-0010 | Hemoglobin A1c assay, Tri-stat Reagent Kit | Trinity Biotech | PRIMUS CORPORATION |
12 | 05391516748162 | Ultra2 Affinity A1c 3000 | 01-04-0080 | Hemoglobin A1c assay, Ultra2 Affinity A1c 3000 | Trinity Biotech | PRIMUS CORPORATION |
13 | 05391516748155 | Ultra2 Affinity HbA1c Analyzer (110V) | 03-01-0052 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (110V) | Trinity Biotech | PRIMUS CORPORATION |
14 | 05391516748148 | Premier Affinity A1c 3000 - 1 kit | 09-03-0007 | Hemoglobin A1c assay, Premier Affinity A1c 3000 - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
15 | 05391516748131 | Premier Affinity A1c 1000 - 1 kit | 09-03-0010 | Hemoglobin A1c assay, Premier Affinity A1c 1000 - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
16 | 05391516748124 | Premier Affinity A1c 500 - 1 kit | 09-03-0008 | Hemoglobin A1c assay, Premier Affinity A1c 500 - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
17 | 05391516748117 | Premier Sample Diluent Reagent - 940mL | 01-03-0101 | Hemoglobin A1c assay, Premier Sample Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
18 | 05391516748100 | Premier Buffer B Reagent - 3.8L | 01-03-0081 | Hemoglobin A1c assay, Premier Buffer B Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
19 | 05391516748094 | Premier Buffer A Reagent - 3.8L | 01-03-0080 | Hemoglobin A1c assay, Premier Buffer A Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
20 | 05391516748063 | Premier Hb9210 HbA1c Analytical Column (500) | 09-06-0050 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (500) | Trinity Biotech | PRIMUS CORPORATION |
21 | 05391516748056 | Premier Hb9210 HbA1c Analytical Column (1000) | 09-06-0046 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (1000) | Trinity Biotech | PRIMUS CORPORATION |
22 | 05391516744799 | Premier Wash Reagent - 940mL | 01-03-0098 | Hemoglobin A1c assay, Premier Wash Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
23 | 05391516744782 | Premier Diluent Reagent - 3.8L | 01-03-0097 | Hemoglobin A1c assay, Premier Diluent Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
24 | 05391516744775 | Premier Buffer B Reagent - 940mL | 01-03-0096 | Hemoglobin A1c assay, Premier Buffer B Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
25 | 05391516744768 | Premier Buffer A Reagent - 940mL | 01-03-0095 | Hemoglobin A1c assay, Premier Buffer A Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
26 | 05391516744751 | Premier Hb9210 HbA1c Analyzer - 1 each | 09-00-0001 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analyzer | Trinity Biotech | PRIMUS CORPORATION |
27 | 05391516744553 | Affinity Analytical Column | 03-02-0079 | Hemoglobin A1c assay, Affinity Analytical Column | Trinity Biotech | PRIMUS CORPORATION |
28 | 05391516744546 | Enzyme Cleaner Tube | 01-12-0001 | Hemoglobin A1c assay, Enzyme Cleaner Tube | Trinity Biotech | PRIMUS CORPORATION |
29 | 05391516744317 | 2 Diluent Reagent - 940mL | 01-03-0059 | Hemoglobin A1c assay, 2 Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
30 | 05391516744294 | 2 Diluent Reagent - 3.8L | 01-03-0058 | Hemoglobin A1c assay, 2 Diluent Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
31 | 05391516744287 | Ultra2 Buffer 2A Reagent - 3.8L | 01-03-0054 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
32 | 05391516744270 | Ultra2 Buffer 2A Reagent - 940mL | 01-03-0053 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
33 | 05391516744218 | System Wash Reagent - 940mL | 01-03-0035 | Hemoglobin A1c assay, System Wash Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
34 | 05391516744171 | Ultra2 Buffer B Reagent - 3.8L | 01-03-0012 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
35 | 05391516744164 | Ultra2 Buffer B Reagent - 940mL | 01-03-0011 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
36 | 05391516744126 | Ultra2 Affinity HbA1c Analyzer (220V) | 03-01-0048 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (220V) | Trinity Biotech | PRIMUS CORPORATION |
37 | 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 |
38 | 05055273208733 | FR4030 | FR4030 | FRUCTOSAMINE (FRUC) | RANDOX LABORATORIES LIMITED | |
39 | 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 |
40 | 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 |
41 | 05055273203554 | HA3450 | HA3450 | HAEMOGLOBIN A1c (HbA1c) | RANDOX LABORATORIES LIMITED | |
42 | 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 |
43 | 04987153301047 | L242GA | L242GA | ALB R-2 Coloring solution 20mL x 2 | Lucica® Glycated Albumin-L ALB R-2 | ASAHI KASEI PHARMA CORPORATION |
44 | 04987153301030 | L232GA | L232GA | ALB R-1 Pretreatment solution 40 mL x 2 | Lucica® Glycated Albumin-L ALB R-1 | ASAHI KASEI PHARMA CORPORATION |
45 | 04987153301023 | L222GA | L222GA | GA R-2 Enzymatic solution 10mL x 2 | Lucica® Glycated Albumin-L GA R-2 | ASAHI KASEI PHARMA CORPORATION |
46 | 04987153301016 | L212GA | L212GA | GA R-1 Pretreatment solution 40 mL x 2 | Lucica® Glycated Albumin-L GA R-1 | ASAHI KASEI PHARMA CORPORATION |
47 | 04560189283640 | N/A | Hemoglobin A1c Calibrator Set | TOSOH CORPORATION | ||
48 | 04560189283626 | N/A | G8 Variant Elution Buffer HSi No.3 (S) | TOSOH CORPORATION | ||
49 | 04560189283619 | N/A | G8 Variant Elution Buffer HSi No.2 (S) | TOSOH CORPORATION | ||
50 | 04560189283602 | N/A | G8 Variant Elution Buffer HSi No.1 (S) | TOSOH CORPORATION |