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 | 04015630942589 | 07528604190 | 07528604190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
2 | 04015630942572 | 07528582190 | 07528582190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
3 | 04015630942565 | 07528566190 | 07528566190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
4 | 04015630926879 | 05401488190 | 05401488190 | HDL-Cholesterol plus 3rd generation | ROCHE DIAGNOSTICS GMBH | |
5 | 00899722002344 | 99021 | 99021 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
6 | 00899722002337 | 99020 | 99020 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
7 | 00893038002654 | 10-991 | 10-991 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
8 | 00893038002647 | 10-990 | 10-990 | Alere Cholestech LDX® TC●HDL●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
9 | 00893038002630 | 10-989 | 10-989 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
10 | 00893038002616 | 10-987 | 10-987 | Alere Cholestech LDX® TC●HDL | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
11 | 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. |
12 | 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. |
13 | 00857969006594 | SA2038 | SA2038 | HDL-C Reagent | ACE | ALFA WASSERMANN, INC. |
14 | 00857969006532 | SA1043 | SA1043 | HDL-C Reagent | ACE | ALFA WASSERMANN, INC. |
15 | 00852169008164 | HDL1210 | HDL1210 | In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL | ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol | CLEARCHEM DIAGNOSTICS INC. |
16 | 00817302023060 | DT616 | DT616 | HDLD (HDL Cholesterol Direct) w/ calibrator 4 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HDLD REAGENT PRODUCT NO. DT616 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
17 | 00817302022216 | CC615 | CC615 | HDLD W/CALIBRATOR, 2 X 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HDL DIRECT CC615 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
18 | 00817302022209 | AU-616 | AU-616 | HDLD (High Density Lipoprotein Direct) w/ cal 3 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HDLD RGT. KIT AU-616 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
19 | 00817302022193 | BL616 | BL616 | HDLD (High Density Lipoprotein Direct) w/ cal 3 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HDL RGT. KIT BL-616 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
20 | 00817302022186 | ST616 | ST616 | HDLD (HDL Cholesterol Direct) w/ cal 2 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HDL RGT KIT Product No. ST616 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
21 | 00817274022856 | HDL4-250 | HDL4-250 | HDL CHOLESTEROL (4x 125mL R1, 4x 42mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
22 | 00817274022252 | HDL4-125 | HDL4-125 | HDL CHOLESTEROL (2x 125mL R1, 2x 42mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
23 | 00817274021705 | XL-HDL4-40 | HDL, CHOLESTEROL (4x 40mL R1, 2x 45mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
24 | 00817274021699 | HDL4-BUL | HDL CHOLESTEROL Bulk | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
25 | 00817274021682 | HDL4-30 | HDL CHOLESTEROL (2x 30mL R1, 2x 10mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
26 | 00817274021675 | DG-HDL4-30 | HDL CHOLESTEROL (2 x 30mL R1, 2 x 10mL R2, 1 x 3mL Standard) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
27 | 00812137012067 | R1 x 2 x 70mL, R2 x 1 x 50mL | 501-419 | The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determ The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease. | HDL Cholesterol Reagent Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
28 | 00657498001561 | S0590-540 | S0590-540 | For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum. | Sirrus® Direct HDL Cholesterol LiquiColor® | STANBIO LABORATORY, L.P. |
29 | 00657498000694 | 0590-500 | 0590-500 | For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum. | Direct HDL Cholesterol LiquiColor® | STANBIO LABORATORY, L.P. |
30 | 00657498000687 | 0590-080 | 0590-080 | For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum. | Direct HDL Cholesterol LiquiColor® | STANBIO LABORATORY, L.P. |
31 | 00657498000670 | 0590-040 | 0590-040 | For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum. | Direct HDL Cholesterol LiquiColor® | STANBIO LABORATORY, L.P. |
32 | 00630414610832 | 11537213 | 11537213 | HDL Cholesterol (HDLC) Atellica CH Assay 1792 Tests | Atellica CH HDLC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
33 | 00630414596204 | 11097630 | 11097630 | Direct HDL Cholesterol (D-HDL) Atellica™ CH - RGT 1792T | Atellica™ CH D-HDL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
34 | 00630414551784 | 10283089 | 6521559 | HDL Cholesterol - ADVIA Chem. - RGT - 6x670 tests | ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
35 | 00630414508436 | 10309507 | 7511947 | HDL Cholesterol - ADVIA Chem. - RGT - 4x326 tests | ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
36 | 00628063400614 | SK6122-20 | SK6122-20 | HDL Ultra Cholesterol Reagent | SEKISUI DIAGNOSTICS, LLC | |
37 | 00628063400591 | 80-6283-00 | 80-6283-00 | Ultra N-geneous HDL Cholesterol Reagent | SEKISUI DIAGNOSTICS, LLC | |
38 | 00628063400584 | 80-6277-00 | 80-6277-00 | Ultra N-geneous HDL Cholesterol Reagent | SEKISUI DIAGNOSTICS, LLC | |
39 | 00628063400553 | 6122 | 6122 | HDL Ultra Cholesterol | SEKISUI DIAGNOSTICS, LLC | |
40 | 00628063400546 | 6121 | 6121 | HDL Ultra Cholesterol | SEKISUI DIAGNOSTICS, LLC | |
41 | 00386100002077 | 10211-4 | 10211-4 | HDL Cholesterol Reagent Kit for use with EasyRA Analyzers | HDL CHOL Reagent Kit | MEDICA CORPORATION |
42 | 00380740161484 | 3K33-22 | 03K3322 | Ultra HDL | ARCHITECT | ABBOTT GMBH |
43 | 00380740129996 | 07P7530 | 07P7530 | Alinity c Ultra HDL Reagent Kit 3500 Tests | Alinity | ABBOTT GMBH |
44 | 00380740129989 | 07P7520 | 07P7520 | Alinity c Ultra HDL Reagent Kit 1400 Tests | Alinity | ABBOTT GMBH |
45 | 00380740005313 | 3K33-21 | 03K3321 | Ultra HDL | ARCHITECT | ABBOTT LABORATORIES |
46 | B3959930030 | 9930030 | 9930030 | NMR Reference Standard used for the Vantera Clinical Analyzer. | NMR Reference Standard | LABCORP OF AMERICA |
47 | B3959920030 | 9920030 | 9920030 | Sample Diluent 1 used for the Vantera Clinical Analyzer. | NMR Diluent 1 | LABCORP OF AMERICA |
48 | B3959910030 | 9910030 | 9910030 | WASH Solution used for the Vantera Clinical Analyzer | NMR WASH Solution | LABCORP OF AMERICA |
49 | B3959900300 | 9900300 | 9900300 | Clinical Analyzer | Vantera Clinical Analyzer | LABCORP OF AMERICA |
50 | 15099590193218 | A15625 | A15625 | HDL Cholesterol Reagent HDL 2 x 200 | Synchron | BECKMAN COULTER, INC. |