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 | 15099590575113 | 467825 | 467825 | Cholesterol Reagent (CHOL 2 x 300) | Synchron | BECKMAN COULTER, INC. |
2 | 15099590060060 | OSR6616 | Cholesterol | AU | BECKMAN COULTER, INC. | |
3 | 15099590020071 | OSR6216 | Cholesterol | AU | BECKMAN COULTER, INC. | |
4 | 15099590010140 | OSR6116 | Cholesterol | AU | BECKMAN COULTER, INC. | |
5 | 10763924550507 | MD550 | Lipid and Glucose Measuring System | LipidPlus® Meter | JANT PHARMACAL CORPORATION | |
6 | 10763924532107 | MD532 | Lipid and Glucose Measuring System | LipidPlus® Total Cholesterol Test Strips | JANT PHARMACAL CORPORATION | |
7 | 10758750031764 | 6844292 | 6844292 | VITROS XT Chemistry Products TRIG-CHOL Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
8 | 10304040037741 | 5700414 | 5700414 | CardioChek Lipid Panel Test | CardioChek | HENRY SCHEIN, INC. |
9 | 10304040037734 | 5700412 | 5700412 | CardioChek 15Lipid/15Glucose | CardioChek | HENRY SCHEIN, INC. |
10 | 08809319396512 | 99LS10-2 | CURO L7 Lipid Test Strip - Lipid Profile | SD BIOSENSOR, INC. | ||
11 | 08809319396161 | 99LA10G-2 | CURO L7 Analyzer | SD BIOSENSOR, INC. | ||
12 | 08809115905413 | ILM-0001A | CURO L5 TC test strip | OSANG HEALTHCARE CO., LTD. | ||
13 | 08809115905406 | ILM-0001A | CURO L5 Meter | OSANG HEALTHCARE CO., LTD. | ||
14 | 07613336121115 | 08057443190 | 08057443190 | Cholesterol | ROCHE DIAGNOSTICS GMBH | |
15 | 05060500091859 | IR060-1200 | IR060-1200 | Cholesterol Reagent 6 X 67 mL + 3 X 54 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
16 | 05060500090623 | IR062-L | IR062-L | Cholesterol Enzyme Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
17 | 05060500090616 | IR061-L | IR061-L | Cholesterol Chromogen Reagent 6 X 1000 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
18 | 05060500090609 | IR060-911 | IR060-911 | Cholesterol Reagent 6 X 50 mL + 3 X 40 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
19 | 05060500090593 | IR060-WK | IR060-WK | Cholesterol Reagent 3 X 25 mL + 3 X 10 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
20 | 05060500090586 | IR060-X | IR060-X | Cholesterol Reagent 1 X 250 mL + 1 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
21 | 05060500090579 | IR060-R | IR060-R | Cholesterol Reagent 3 X 250 mL + 3 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
22 | 05055273208474 | CH8310 | For the quantitative in vitro determination of cholesterol in serum and plasma. | CHOLESTEROL (CHOL) | RANDOX LABORATORIES LIMITED | |
23 | 05055273208443 | CH8019 | CHOLESTEROL (CHOL) | RANDOX LABORATORIES LIMITED | ||
24 | 05055273201284 | CH3810 | CH3810 | For the quantitative in vitro determination of cholesterol in serum and plasma. | CHOL | RANDOX LABORATORIES LIMITED |
25 | 04571226470831 | 14-531 | 14-531 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
26 | 04015630924967 | 05168538190 | 05168538190 | Cholesterol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
27 | 04015630922062 | 04718917190 | 04718917190 | Cholesterol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
28 | 04015630918430 | 3039773190 | 03039773190 | Cholesterol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
29 | 03610230006917 | 1300023838 | Yumizen C1200 Cholesterol | HORIBA ABX SAS | ||
30 | 03610230004975 | 1220001634 | ABX PENTRA CHOLESTEROL CP | HORIBA ABX SAS | ||
31 | 00899722002344 | 99021 | 99021 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
32 | 00899722002337 | 99020 | 99020 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
33 | 00893038002654 | 10-991 | 10-991 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
34 | 00893038002647 | 10-990 | 10-990 | Alere Cholestech LDX® TC●HDL●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
35 | 00893038002630 | 10-989 | 10-989 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
36 | 00893038002623 | 10-988 | 10-988 | Alere Cholestech LDX® TC●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
37 | 00893038002616 | 10-987 | 10-987 | Alere Cholestech LDX® TC●HDL | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
38 | 00893038002609 | 10-986 | 10-986 | Alere Cholestech LDX® TC | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
39 | EABA40000301 | 400-0030 | 400-0030 | The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Lipid Panel Plus | ABAXIS, INC. |
40 | EABA40000251 | 400-0025 | 400-0025 | The Piccolo® Lipid Panel reagent disc, used with the Piccolo® blood chemistry an The Piccolo® Lipid Panel reagent disc, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® Chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), and triglycerides (TRIG) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From these determinations low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Lipid Panel | ABAXIS, INC. |
41 | 00860394001256 | CURO L5 Total Cholesterol Strips | Total Cholesterol Strips | CURO L5 Total Cholesterol Strips | KPI HEALTHCARE, INC. | |
42 | 00860394001225 | CURO L5 CURO L5 | CURO L5 Cholesterol and Glucose measuring system | CURO L5 | KPI HEALTHCARE, INC. | |
43 | 00857969006488 | SA1010 | SA1010 | Cholesterol Reagent | ACE | ALFA WASSERMANN, INC. |
44 | 00857969006440 | RX1010 | RX1010 | Cholesterol Reagent | ACE | ALFA WASSERMANN, INC. |
45 | 00852169008157 | CHL1100 | CHL1100 | In Vitro Diagnostics testing kit R1:4X60mL | ClearChem Diagnostics Inc. Cholesterol, Total | CLEARCHEM DIAGNOSTICS INC. |
46 | 00850014861346 | TD-4289 | HeartsCare C1 Total Cholesterol Test Strip (10pcs/box) | HEARTS BIO, INC. | ||
47 | 00850006113064 | Curo L5 | CURO L5 Glucose Strip | Curo L5 | KPI HEALTHCARE, INC. | |
48 | 00842768015090 | 10445143 | K1027 | Cholesterol Flex® reagent cartridge, 600 tests | Dimension Vista® Flex® reagent cartridge CHOL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00842768005466 | 10444891 | DF27 | Cholesterol Flex® reagent cartridge, 480 tests | Dimension® Flex® reagent cartridge CHOL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00817302024548 | ST211 | ST211 | Cholesterol (CHOL) Reagent | CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT ST211 | CAROLINA LIQUID CHEMISTRIES CORPORATION |