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 | 15099590012120 | B93009 | HbA1c Advanced | AU | BECKMAN COULTER IRELAND INC. | |
2 | 10758750030729 | 6842905 | 6842905 | VITROS Chemistry Products HbA1c Reagent | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
3 | 07613336157824 | 08445699190 | 08445699190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
4 | 07613336120927 | 08056668190 | 08056668190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
5 | 07070060014555 | 1116794 | 1116794 | Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in hum Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in human whole blood including diagnosis. COntetns: 15 test cartridges, 1 package insert. | Afinion HbA1c Dx | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
6 | 07070060012889 | 1116482 | 1116482 | 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 including diagnosis. Contents: 15 Test Cartridges. 1 Package Insert. | Afinion HbA1c Dx | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
7 | 06935784430016 | BH60 | HP-M51 | The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic use for the quantitative measurement of HbA1c in whole blood specimens in combination with Glycohemoglobin Analytical Column and Glycohemoglobin Reagent Kit produced by Wuxi Biohermes Bio & Medical Technology Co., Ltd. using ion-exchange high-performance liquid chromatography (HPLC). | BioHermes Automated Glycohemoglobin Analyzer | WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO.,LTD. |
8 | 04987486015130 | 103399 | These products are used with the ADAMS A1c HA-8180 series for the determination These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes commercially available freeze-dried controls and dilutes white blood samples. | DILUENT 80 | ARKRAY USA, INC. | |
9 | 04987486015123 | 103398 | These products are used with the ADAMS A1c HA-8180 series for the determination These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes whole blood samples and is used to wash the sample tubes. | HEMOLYSIS WASHING SOLUTION 80H | ARKRAY USA, INC. | |
10 | 04987486015116 | 103397 | These products are used with the ADAMS A1c HA-8180 series for the determination These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength. | ELUENT 80CV | ARKRAY USA, INC. | |
11 | 04987486015109 | 103396 | These products are used with the ADAMS A1c HA-8180 series for the determination These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength. | ELUENT 80B | ARKRAY USA, INC. | |
12 | 04987486015093 | 103395 | These products are used with the ADAMS A1c HA-8180 series for the determination These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength. | ELUENT 80A | ARKRAY USA, INC. | |
13 | 04987486001973 | 100675 | The ADAMS A1c HA-8180V system is intended for the quantitative determination of The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC). | ADAMS™ A1c HA-8180V (UL) Analyzer | ARKRAY USA, INC. | |
14 | 04015630942787 | 07559674190 | 07559674190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
15 | 04015630934560 | 04528123160 | 04528123160 | Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application | ROCHE DIAGNOSTICS GMBH | |
16 | 03610521164319 | 12005706 | 12005706 | D-10 Hemoglobin A1c Program Calibrator/Diluent Set | D-10 | BIO-RAD LABORATORIES, INC. |
17 | 03610521164302 | 12005707 | 12005707 | D-10 Hemoglobin A1c Program Analytical Cartridge | D-10 | BIO-RAD LABORATORIES, INC. |
18 | 03610520530108 | 12000949 | 12000949 | D-10 Hemoglobin A1c Program | D-10 | BIO-RAD LABORATORIES, INC. |
19 | 03610520506547 | 12000447 | 12000447 | VARIANT II TURBO HbA1c Kit - 2.0 | VARIANT II TURBO | BIO-RAD LABORATORIES, INC. |
20 | 03607360025154 | 2515 | 2515 | Device intended for measurement of HbA1c in whole blood using capillary electrophoresis | CAPI 3 Hb A1c | SEBIA |
21 | 00847817025693 | 290-1007 | 2901007 | D-100 Prefilter | D-100 | BIO-RAD LABORATORIES, INC. |
22 | 00847817025679 | 290-1010 | 2901010 | D-100 HbA1c Elution Buffer A | D-100 | BIO-RAD LABORATORIES, INC. |
23 | 00847817016035 | 290-1012 | 2901012 | D-100 Wash Solution | D-100 | BIO-RAD LABORATORIES, INC. |
24 | 00847817016028 | 290-1011 | 2901011 | D-100 HbA1c Elution Buffer B | D-100 | BIO-RAD LABORATORIES, INC. |
25 | 00847817016004 | 290-1009 | 2901009 | D-100 Sample Diluent | D-100 | BIO-RAD LABORATORIES, INC. |
26 | 00630414220505 | 11097536 | 11097536 | Enzymatic Hemoglobin A1c_E (A1c_E) Atellica CH - RGT 600T | Atellica CH A1c_E | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
27 | 00630414006666 | 10720885 | K3105B | A1C Reagent Kit | Dimension Vista System Flex reagent cartridge A1C KIT | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
28 | 00630414006659 | 10720883 | DF105B | A1C Reagent Kit | Dimension Clinical Chemistry System A1C Kit | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
29 | 00630414002880 | 10721048 | 10721048 | ADVIA A1c_E Pretreatment Solution, 1L | ADVIA Chemistry Enzymatic hemoglobin A1c Pretreatment | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
30 | 00630414002866 | 10720858 | 10720858 | ADVIA A1c_E Reagent (Large Kit), 1200 tests | ADVIA Chemistry Enzymatic Hemoglobin A1c | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
31 | 00630414002859 | 10720857 | 10720857 | ADVIA A1c_E Reagent (Small Kit), 300 tests | ADVIA Chemistry Enzymatic Hemoglobin A1c | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
32 | 00628063401147 | SK350-60 | SK350-60 | HbA1c Assay | SEKISUI DIAGNOSTICS, LLC | |
33 | 00380740135591 | 08P4320 | 08P4320 | Alinity c Hemoglobin A1c Reagent Kit 1300 Tests | Alinity | ABBOTT GMBH |
34 | 00380740102746 | 4P52-20 | 04P5220 | Hemoglobin A1c | ARCHITECT | ABBOTT GMBH |
35 | 00380740102739 | 4P52-11 | 04P5211 | Hemoglobin A1c Controls | ARCHITECT | ABBOTT GMBH |
36 | 00380740102722 | 4P52-01 | 04P5201 | Hemoglobin A1c Calibrators | ARCHITECT | ABBOTT GMBH |