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 | 10883489084849 | GE100 | 99GM555CZ1 | The combination products includes 2 boxes(00883489001207) of meters(008834890011 The combination products includes 2 boxes(00883489001207) of meters(00883489001191) and 8 boxes(00883489001245) of strips(00883489001238) | GE | BIONIME CORPORATION |
2 | 10850081003011 | MGH-TS50-FDA | Glucose Test Strip Vial Label | MyGlucoHealth Test Strips | ENTRA HEALTH SYSTEMS LLC | |
3 | 10763924550507 | MD550 | Lipid and Glucose Measuring System | LipidPlus® Meter | JANT PHARMACAL CORPORATION | |
4 | 10758750031795 | 6844295 | 6844295 | VITROS XT Chemistry Products GLU-Ca Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
5 | 10758750009572 | 1707801 | 1707801 | VITROS Chemistry Products GLU Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
6 | 10673486000719 | Glucopad Blood Glucose Monitoring System | G852-C-001 | Glucopad Blood Glucose Monitoring System (BGMS) is for self testing use and it c Glucopad Blood Glucose Monitoring System (BGMS) is for self testing use and it consists of a blood glucose meter, and blood glucose test strips. | TECO DIAGNOSTICS | TECO DIAGNOSTICS |
7 | 10612479212784 | 5059 | GLUCOSE TEST STRIP WITH PURPLE COLOR | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
8 | 10385480434376 | GLU | 43437 | Nova Max Glucose Test Strips | NOVA MAX | NOVA BIOMEDICAL CORPORATION |
9 | 10385480422144 | GLU Test Strip | 42214 | StatStrip StatStrip Xpress Glu - Test Strips | StatStrip | NOVA BIOMEDICAL CORPORATION |
10 | 10304040037734 | 5700412 | 5700412 | CardioChek 15Lipid/15Glucose | CardioChek | HENRY SCHEIN, INC. |
11 | 10304040037727 | 5700415 | 5700415 | Cardiochek eGLU Glucose Test | CardioChek | HENRY SCHEIN, INC. |
12 | 10052569138479 | TRUEtrack PRE-PACK | A4089-75 | Health Mart PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
13 | 10021292008625 | TRUEtrack PRE-PACK | A4027-75 | Preferred Plus Pharmacy TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
14 | 10021292008618 | TRUEtrack PRE-PACK | A4011-75 | GOOD NEIGHBOR PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
15 | 10021292006874 | TRUEtrack PRE-PACK | A4088-75 | HealthWise PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
16 | 10021292006867 | TRUEtrack PRE-PACK | A4054-75 | Sunmark TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
17 | 10021292006843 | TRUEtrack PRE-PACK | A4H01-75 | TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
18 | 08809301168134 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
19 | 08809301168127 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
20 | 08809301168110 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
21 | 08809301168103 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
22 | 08809301168097 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
23 | 08809301168080 | GT-301 | GlucoTrack Voice Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
24 | 08809301168042 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
25 | 08809301168011 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
26 | 08809301166031 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
27 | 08809301166017 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
28 | 08809301166000 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
29 | 08809301161760 | PS-004 | Pip Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
30 | 08809301161036 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
31 | 08809301161029 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
32 | 08809301160862 | PG-310 | Pip Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
33 | 08809301160411 | PG-101 | Gmate Smart Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
34 | 08809301160213 | PG-301 | Gmate® VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
35 | 08809301160206 | PG-310 | Gmate® Origin Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
36 | 08809301160169 | PG-201 | Gmate® STEP Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
37 | 08809301160152 | PG-200 | Gmate® mini Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
38 | 08809301160145 | PG-310 | Gmate® Origin Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
39 | 08809301160138 | PG-301 | Gmate® VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
40 | 08809301160121 | PG-201 | Gmate® STEP Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
41 | 08809301160114 | PG-200 | Gmate® mini Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
42 | 08809301160084 | PG-301 | Gmate® VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
43 | 08809301160077 | PG-310 | Gmate® Origin Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
44 | 08809301160022 | PG-201 | Gmate® STEP Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
45 | 08809301160015 | PG-200 | Gmate® mini Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
46 | 08809115908971 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Meter | OSANG HEALTHCARE CO., LTD. | |
47 | 08809115908957 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Test Strips | OSANG HEALTHCARE CO., LTD. | |
48 | 08809115908452 | IGM-0021B | Blood Glucose Monitoring System | Element™ Meter | OSANG HEALTHCARE CO., LTD. | |
49 | 08809115908438 | IGM-0021B | Blood Glucose Monitoring System | Element™ Test Strips | OSANG HEALTHCARE CO., LTD. | |
50 | 07311091207074 | 120707 | 120707 | HemoCue Glucose 201 Analyzer mmol/L whole blood | HemoCue® Glucose 201 Analyzer | HEMOCUE AB |