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 | 00630414034348 | 11065645 | 11065645 | Xprecia™ System PT/INR Strips, is intended for use by professional healthcare pr Xprecia™ System PT/INR Strips, is intended for use by professional healthcare providers to provide an INR (International NormalizedRatio) based on a prothrombin time (PT) response for the monitoring of oral anticoagulation therapy with warfarin | Xprecia™ System PT/INR Strips | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
2 | 00630414025148 | 11065584 | 11065584 | The Xprecia Stride™ Coagulation System is intended for use by professional healt The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin. | Xprecia Stride™ Coagulation Analyzer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
3 | 00630414023496 | 10873568 | B4212-101 | For use in prothrombin time (PT) determinations and prothrombin time-based assay For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma | Dade® Innovin® | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
4 | 00630414023489 | 10873567 | B4212-51 | For use in prothrombin time (PT) determinations and prothrombin time-based assay For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma | Dade® Innovin® | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
5 | 00630414023472 | 10873566 | B4212-41 | For use in prothrombin time (PT) determinations and prothrombin time-based assay For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma | Dade® Innovin® | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
6 | 00630414023465 | 10873565 | OUHP53 | Determination of prothrombin time (PT) and of the activity of coagulation factor Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X | Thromborel® S | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
7 | 00630414023441 | 10873564 | OUHP31 | Determination of prothrombin time (PT) and of the activity of coagulation factor Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X | Thromborel® S | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
8 | 00627944000035 | 10 mL | QuikCoag PT-HS | BIOMEDICA DIAGNOSTICS INC | ||
9 | 00627944000028 | 4 mL | QuikCoag PT-HS | BIOMEDICA DIAGNOSTICS INC | ||
10 | 00627944000011 | 2 mL | QuikCoag PT-HS | BIOMEDICA DIAGNOSTICS INC | ||
11 | 00385480498487 | PHOX PLUS | 49848 | Stat Profile pHOx Plus Air Detector | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
12 | 00385480347174 | PHOX PLUS L | 34717 | Remanufactured Stat Profile pHOx Plus L Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
13 | 00385480346436 | PHOX PLUS/C | 34643 | STAT PROFILE pHOx PLUS/C PROBE | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
14 | 00385480340816 | PHOX PLUS L | 34081 | Stat Profile pHOx Plus L Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
15 | 00385480322041 | PHOX PLUS | 32204 | Remanufactured Stat Profile pHOx Plus Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
16 | 00385480278072 | PHOX PLUS | 27807 | STAT PROFILE pHOx PLUS SENSOR MODULE REPLACEMENT | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
17 | 00385480278034 | PHOX PLUS | 27803 | Stat Profile pHOx Plus Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
18 | 00385480248198 | CCX/PHOX/BASIC/PLUS/L/C | 24819 | Stat Profile CCX Stat Profile pHOx/Basic/Plus/L/C/M Control Flush Fixture | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
19 | 00385480243278 | PHOX/BASIC/PLUS/L/C | 24327 | STAT PROFILE pHOx/BASIC/PLUS/L/C FLUSH FIXTURE | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
20 | 00385480225076 | pHOx/BASIC/PLUS/L/C | 22507 | STAT PROFILE pHOx/BASIC/PLUS/L/C SENSOR | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
21 | 00385480214971 | pHOx/BASIC/PLUS/L/C | 21497 | STAT PROFILE pHOx/BASIC/PLUS/L/C REFERENCE LINE ASSEMBLY | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
22 | 00365702700499 | 07729952160 | 07729952160 | CoaguChek Vantus (USA) | CoaguChek Vantus System | ROCHE DIAGNOSTICS GMBH |
23 | 00365702398108 | 5530199160 | 5530199160 | CoaguChek XS Pro Kit | ROCHE DIAGNOSTICS GMBH | |
24 | 00365702164109 | 5021537001 | 5021537001 | CoaguChek XS Plus Professional Care Kit | ROCHE DIAGNOSTICS GMBH | |
25 | 00365702128101 | 4625315160 | 4625315160 | CoaguChek XS PT strips | ROCHE DIAGNOSTICS GMBH | |
26 | 00365702127104 | 4625374160 | 4625374160 | COAGUCHEK XS PT TEST 6 STRIP | ROCHE DIAGNOSTICS GMBH | |
27 | 00365702126107 | 4837975001 | 4837975001 | CoaguChek XS Professional Use Care Kit | ROCHE DIAGNOSTICS GMBH | |
28 | 00365702125100 | 4837738001 | 4837738001 | CoaguChek XS Patient Self Testing Care Kit | ROCHE DIAGNOSTICS GMBH | |
29 | 15391521420241 | T1102 | TriniCLOT™ PT HTF 6 mL | TCOAG IRELAND LIMITED | ||
30 | 15391521420234 | T1101 | TriniCLOT™ PT HTF 20 mL | TCOAG IRELAND LIMITED | ||
31 | 13607450007456 | 00745 | STA® - Deficient II | DIAGNOSTICA STAGO | ||
32 | 13607450007449 | 00744 | STA® - Deficient V | DIAGNOSTICA STAGO | ||
33 | 10859394006030 | 11-310 | 11-310 | PT reagent 10 x 10 ml | Phosphoplastin RL | R 2 DIAGNOSTICS, INC. |
34 | 10859394006023 | 11-305 | 11-305 | PT reagent 10 x 5 ml | Phosphoplastin RL | R 2 DIAGNOSTICS, INC. |
35 | 10711234103043 | J201C | J201C | Citrate PT Cuvette - 45 test cuvettes/box. | Hemochron Whole Blood Microcoagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
36 | 10711234103036 | J201 | J201 | PT Cuvette - 45 test cuvettes/box. | Hemochron Whole Blood Microcoagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
37 | M52552490 | 5249 | Thromboplastin-LI Reagent Kit | HELENA LABORATORIES CORPORATION | ||
38 | M52552480 | 5248 | Thromboplastin-LI Reagent Kit | HELENA LABORATORIES CORPORATION | ||
39 | 10054749000170 | 03P89-24 | 03P89-24 | PT Cartridge | i-STAT | ABBOTT POINT OF CARE INC. |
40 | M30401001393 | 0100139 | 0100139 | INRatio 48 Pack Strips, U.S. | Alere INRatio® | ALERE SAN DIEGO, INC. |
41 | M30401000713 | 0100071 | 0100071 | INRatio 12 Pack Strips, U.S. | Alere INRatio® | ALERE SAN DIEGO, INC. |
42 | 08436540290816 | KTC0001AD | microINR ® Meter | ILINE MICROSYSTEMS SL | ||
43 | 08436540290717 | CHC0025AD | microINR ® CHIPS | ILINE MICROSYSTEMS SL | ||
44 | 08426950632887 | 00020301400 | 00020301400 | HemosIL ReadiPlasTin (20 mL) | HemosIL ReadiPlasTin (20 mL) | INSTRUMENTATION LABORATORY COMPANY |
45 | 08426950632870 | 00020301300 | 00020301300 | HemosIL ReadiPlasTin (10 mL) | HemosIL ReadiPlasTin (10 mL) | INSTRUMENTATION LABORATORY COMPANY |
46 | 08426950453079 | 00020002950 | 00020002950 | HemosIL RecombiPlasTin 2G (8 mL) | HemosIL RecombiPlasTin 2G (8 mL) | INSTRUMENTATION LABORATORY COMPANY |
47 | 08426950452836 | 00009756710 | 00009756710 | HemosIL PT-Fibrinogen | HemosIL PT-Fibrinogen | INSTRUMENTATION LABORATORY COMPANY |
48 | 08426950447627 | 00020003050 | 00020003050 | HemosIL RecombiPlasTin 2G (20 mL) | HemosIL RecombiPlasTin 2G (20 mL) | INSTRUMENTATION LABORATORY COMPANY |
49 | 08426950058403 | 00008469810 | 00008469810 | HemosIL PT-Fibrinogen HS PLUS | HemosIL PT-Fibrinogen HS PLUS | INSTRUMENTATION LABORATORY COMPANY |
50 | 05391521420282 | T1106 | TriniCLOT™ PT Excel 6 mL | TCOAG IRELAND LIMITED |