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 | 00888277721053 | MPH1540NV | MPH1540NV | METER, GLUCOSE. EVENCARE G2 | Medline | MEDLINE INDUSTRIES, INC. |
2 | 00887473000160 | 01GS11 | SD GlucoNavii Blood Glucose Test Strip | SD BIOSENSOR, INC. | ||
3 | 00887473000139 | 01GCS10 | SD Glucose Control Solution | SD BIOSENSOR, INC. | ||
4 | 00887473000122 | 01GS11C | SD GlucoNavii Blood Glucose Test Strip | SD BIOSENSOR, INC. | ||
5 | 00887473000108 | 01GC110 | SD GlucoNavii Blood Glucose Monitoring System | SD BIOSENSOR, INC. | ||
6 | 00887473000016 | 01GM11 | SD GlucoNavii Blood Glucose Monitoring System | SD BIOSENSOR, INC. | ||
7 | 00887473000009 | 01GC111 | SD GlucoNavii Blood Glucose Monitoring System | SD BIOSENSOR, INC. | ||
8 | 00885502001041 | IGM-0009 | IGM-G3-103 | Control™ Meter Kit | U.S. DIAGNOSTICS INC. | |
9 | 00885502001034 | IGM-0008 | IGM-G2-103 | EasyGluco™G2 Meter Kit | U.S. DIAGNOSTICS INC. | |
10 | 00885502001003 | IGM-0024 | G5-103MK | INFINITY™ Meter Kit | U.S. DIAGNOSTICS INC. | |
11 | 00885502000044 | IGM-0009 | IGM-G3-003 | Control™ Starter Kit | U.S. DIAGNOSTICS INC. | |
12 | 00885502000037 | IGM-0008 | IGM-G2-101 | EasyGluco™G2 Starter Kit | U.S. DIAGNOSTICS INC. | |
13 | 00885502000006 | IGM-0024 | G5-003SK | INFINITY™ Starter Kit | U.S. DIAGNOSTICS INC. | |
14 | 00885325001693 | 164503 | CareSens N Feliz Blood Glucose Monitoring System | CareSens N Feliz | I-SENS, INC. | |
15 | 00885325001686 | 164508 | CareSens N Feliz BT Blood Glucose Monitoring System | CareSens N Feliz BT | I-SENS, INC. | |
16 | 00885325001402 | 343262 | Tempo Blood Glucose Monitoring System | Tempo | I-SENS, INC. | |
17 | 00885325001389 | 343264 | Tempo Blood Glucose Monitoring System | Tempo | I-SENS, INC. | |
18 | 00885325001372 | 164372 | CareSens N Plus BT Blood Glucose Monitoring System | CareSens N Plus BT | I-SENS, INC. | |
19 | 00885325001327 | 164307 | CareSens N Blood Glucose Monitoring System | CareSens N | I-SENS, INC. | |
20 | 00885325001310 | 164284 | CareSens N Blood Glucose Monitoring System | CareSens N | I-SENS, INC. | |
21 | 00885325001266 | 164221 | CareSens II Blood Glucose Monitoring System (Basic meter set) | CareSens II | I-SENS, INC. | |
22 | 00885325001211 | 164303-204 | CareSens N Blood Glucose Monitoring System with Test Strips (10T) | CareSens N | I-SENS, INC. | |
23 | 00885325001105 | 164303-203 | CareSens N Blood Glucose Monitoring System (White) | CareSens N | I-SENS, INC. | |
24 | 00885325000849 | 164446-201 | CareSens N Voice Multi Blood Glucose Monitoring System | CareSens N Voice Multi | I-SENS, INC. | |
25 | 00885325000757 | 520001 | COOL Blood Glucose Meter | COOL | I-SENS, INC. | |
26 | 00885325000443 | 164442-202 | CareSens N Voice Blood Glucose Meter | CareSens N Voice | I-SENS, INC. | |
27 | 00885325000436 | 164422 | CareSens N POP Blood Glucose Monitoring System | CareSens N POP | I-SENS, INC. | |
28 | 00885325000375 | 521100 | COOL Blood Glucose Monitoring System | COOL | I-SENS, INC. | |
29 | 00885325000115 | 164301-202 | CareSens N Blood Glucose Meter | CareSens N | I-SENS, INC. | |
30 | 00885325000047 | 155300-201 | CareSens N Blood Glucose Meter | CareSens N (MedPoint Diagnostics) | I-SENS, INC. | |
31 | 00885325000016 | 164303-201 | CareSens N Blood Glucose Monitoring System | CareSens N | I-SENS, INC. | |
32 | 00885017000638 | EM44 | a bottle of level 2 control solution | EM 15 Blood Glucose Level 2 Control Solution | EPS BIO TECHNOLOGY CORP. | |
33 | 00885017000591 | EasyMax | 1 bottle of Level 2 Control Solution | EasyMax Blood Glucose Level 2 Control Solution | EPS BIO TECHNOLOGY CORP. | |
34 | 00885017000584 | EM44 | a bottle of level 1 and a bottle of level 2 control solution | EM 15 Blood Glucose Level 1 and Level 2 Control Solution | EPS BIO TECHNOLOGY CORP. | |
35 | 00885017000560 | EM44 | a bottle of level 2 control solution | EasyMax 15 NHCS Set EN | EPS BIO TECHNOLOGY CORP. | |
36 | 00885017000553 | EasyMax | 1 bottle of Level 2 Solution | EasyMax NHCS Set EN | EPS BIO TECHNOLOGY CORP. | |
37 | 00885017000461 | EM66 | 1 blood glucose meter; 10 strips in a vial; level 2 control solution in a convenience kit | FortisCare Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
38 | 00885017000447 | EM44 | 50 strips in a vial | FortisCare Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
39 | 00885017000416 | EM44 | 50 strips in a vial | EasyMax 15 Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
40 | 00885017000362 | EM44 | a bottle of level 1 control solution | EM 15 Blood Glucose Level 1 Control Solution | EPS BIO TECHNOLOGY CORP. | |
41 | 00885017000355 | EasyMax | 10 strips in a vial | EasyMax Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
42 | 00885017000324 | EMMU | 1 blood glucose meter; 10 strips in a vial; level 2 control solution, 10 lancets 1 blood glucose meter; 10 strips in a vial; level 2 control solution, 10 lancets, 1 lancing device in a convenience kit.1 blood glucose meter; 10 strips in a vial; level 2 control solution, 5 lancets, 1 lancing device in a convenience kit. (10885017000321) | EasyMax NG Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
43 | 00885017000317 | EasyMax T1 Pro | 50 strips in a vial | FortisCare Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
44 | 00885017000300 | EasyMax T1 Pro | 1 blood glucose meter | FortisCare Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
45 | 00885017000287 | EASY MAX 15 | The EASY MAX 15 Glucose Test Strips are intended for the quantitative measuremen The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. The test Strips must be used with the EASY MAX 15 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, is not for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions. | 25 EasyMax 15 FTS Set EN-ES | EPS BIO TECHNOLOGY CORP. | |
46 | 00885017000270 | EASY MAX | The EASY MAX Glucose Test Strips are intended for the quantitative measurement o The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. The EASY MAX Glucose Test Strips must be used with the EASY MAX Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. | 25 EasyMax FTS Set EN-ES | EPS BIO TECHNOLOGY CORP. | |
47 | 00885017000263 | EasyMax G1 FTS | 25 strips in a vial. | FortisCare Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
48 | 00885017000171 | EM44 | 10 strips in a vial | EasyMax 15 Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
49 | 00885017000102 | EMMU | Semi kit: one blood glucose meter | EasyMax LTC Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
50 | 00885017000065 | EMMU | Semi kit: one blood glucose meter | EasyMax NG Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. |