No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00628063400393 | 265-30 | 265-30 | JFY | ENZYMATIC METHOD, CREATININE | 2 | ENZYMATIC CREATININE Assay | |
2 | 00628063400362 | 234-99 | 234-99 | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | 1 | CHOLESTEROL-SL | |
3 | 00628063400355 | 234-60 | 234-60 | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | CHOLESTEROL-SL | ||
4 | 00742860100215 | 1005 | 1005 | OSOM Ultra Flu A&B Controls 5 Test | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | OSOM Ultra Flu A&B Controls 5 Test | |
5 | 00628063400676 | 80-4598-00 | 80-4598-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R1) | |
6 | 00628063400669 | 7120 | 7120 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | LDL Direct LS Cholesterol Reagent Kit | |
7 | 00742860001017 | 101 | 101 | JHI | Visual, pregnancy hCG, prescription use | OSOM hCG Urine 50 Test Kit | ||
8 | 00628063400539 | SK235-10 | SK235-10 | CFR | HEXOKINASE, GLUCOSE | GLUCOSE | ||
9 | 00628063401154 | SK350-CAL | SK350-CAL | JIT | Calibrator, secondary | 2 | HbA1c Calibrators | |
10 | 00628063401116 | SK252-20 | SK252-20 | DCF | ALBUMIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Microalbumin | |
11 | 00628063400690 | 80-4604-00 | 80-4604-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R1) | |
12 | 00628063400652 | 327-30 | 327-30 | CFJ | NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE | 2 | LACTATE DEHRYDROGENASE-SL Assay | |
13 | 00628063400225 | SK284-20 | SK284-20 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Total Bilirubin | |
14 | 00628063400164 | 247-30 | 247-30 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | DIRECT BILIRUBIN-SL Assay | |
15 | 00628063400089 | 328-30 | 328-30 | CJE | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES | 2 | ALKALINE PHOSPHATASE-SL | |
16 | 00742860100161 | 175 | 175 | LYR | Helicobacter pylori | OSOM H Pylori 25 Test Kit | ||
17 | 00628063401086 | SK273-40 | SK273-40 | DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | 2 | Ethanol Assay | |
18 | 00742860001475 | 147 | 147 | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | OSOM Ultra Strep A 25 Test Kit | ||
19 | 00628063400867 | 511-40 | 511-40 | DKJ | COLORIMETRY, SALICYLATE | 2 | SALICYLATE-SL Assay | |
20 | 00628063400850 | SK117-20 | SK117-20 | CEO | Phosphomolybdate (colorimetric), inorganic phosphorus | 1 | PHOSPHORUS | |
21 | 00628063400799 | 175-12 | 175-12 | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | MAGNESIUM Reagent | ||
22 | 00742860001024 | 102W | 102W | JHI | Visual, pregnancy hCG, prescription use | OSOM hCG Card 25 Test Kit | ||
23 | 00742860100093 | 138 | 138 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HCG SERUM CONTROL KIT | |
24 | 00628063401178 | SK350-BLK | SK350-BLK | JIT | Calibrator, secondary | HbA1c Blank Solution | ||
25 | 00628063401161 | SK350-QC | SK350-QC | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HbA1c Controls | |
26 | 00628063401147 | SK350-60 | SK350-60 | PDJ,LCP | Hemoglobin A1c test system,ASSAY, GLYCOSYLATED HEMOGLOBIN | 2 | HbA1c Assay | |
27 | 00628063400454 | SM-052 | SM-052 | JJY | Multi-analyte controls, all kinds (assayed) | DC-TROL Level 1 | ||
28 | 00628063400430 | 250-20 | 250-20 | DCK | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | 2 | Wide Range CRP Assay | |
29 | 00628063400140 | 319-30 | 319-30 | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | AST-SL | |
30 | 00628063400072 | SK200-10 | SK200-10 | CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN | ALBUMIN | ||
31 | 00742860100222 | 1006 | 1006 | OSOM Ultra Flu A&B 25T Kit | PSZ | Devices detecting influenza A, B, and C virus antigens | OSOM Ultra Flu A&B 25T Kit | |
32 | 00742860100147 | 191 | 191 | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | OSOM Influenza Control Kit | ||
33 | 00742860001499 | 149 | 149 | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | OSOM Ultra Strep A 50 Test Kit | ||
34 | 00742860100178 | 176 | 176 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | OSOM H. Pylori Control Kit | |
35 | 00742860001451 | 145 | 145 | KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | OSOM Mono 25 Test Kit | ||
36 | 00628063400935 | 153-90 | 153-90 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
37 | 00628063400928 | 153-10 | 153-10 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
38 | 00742860100048 | 755725 | 755725 | KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | MONO, MERIDIAN IMMUNO 25 Test Kit | ||
39 | 00628063400980 | SK283-10 | SK283-10 | CDQ | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN | UREA | ||
40 | 00628063400959 | 153-50 | 153-50 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
41 | 00628063400942 | 153-30 | 153-30 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
42 | 00628063400904 | 236-99 | 236-99 | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | 1 | TRIGLYCERIDE-SL | |
43 | 00628063400898 | 236-60 | 236-60 | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | TRIGLYCERIDE-SL | ||
44 | 00628063400836 | SE-252 | SE-252 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | MICROALBUMIN Calibrators | |
45 | 00628063400744 | 80-5666-02 | 80-5666-02 | JIS | CALIBRATOR, PRIMARY | N-geneous LDL-ST Cholesterol Calibrator | ||
46 | 00628063400492 | 273-30 | 273-30 | DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | 2 | ETHANOL L3K Assasy | |
47 | 00742860100406 | 1034 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | OSOM ULTRA PLUS FLU A&B Control Kit | ||
48 | 00742860100345 | 1031 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | Acucy Calibration Device | ||
49 | 00628063400805 | 450-50 | 450-50 | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | TOTAL PROTEIN (MICRO) Assay | |
50 | 00628063400706 | 80-4607-00 | 80-4607-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R2) |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04571226470831 | 14-531 | 14-531 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
2 | 04015630942589 | 07528604190 | 07528604190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
3 | 04015630942572 | 07528582190 | 07528582190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
4 | 04015630942565 | 07528566190 | 07528566190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
5 | 04015630926879 | 05401488190 | 05401488190 | HDL-Cholesterol plus 3rd generation | ROCHE DIAGNOSTICS GMBH | |
6 | 00899722002344 | 99021 | 99021 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
7 | 00899722002337 | 99020 | 99020 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
8 | 00893038002654 | 10-991 | 10-991 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
9 | 00893038002647 | 10-990 | 10-990 | Alere Cholestech LDX® TC●HDL●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
10 | 00893038002630 | 10-989 | 10-989 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
11 | 00893038002616 | 10-987 | 10-987 | Alere Cholestech LDX® TC●HDL | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
12 | 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. |
13 | 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. |
14 | 00857969006594 | SA2038 | SA2038 | HDL-C Reagent | ACE | ALFA WASSERMANN, INC. |
15 | 00857969006532 | SA1043 | SA1043 | HDL-C Reagent | ACE | ALFA WASSERMANN, INC. |
16 | 00852169008164 | HDL1210 | HDL1210 | In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL | ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol | CLEARCHEM DIAGNOSTICS INC. |
17 | 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 |
18 | 00817302022216 | CC615 | CC615 | HDLD W/CALIBRATOR, 2 X 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HDL DIRECT CC615 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
19 | 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 |
20 | 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 |
21 | 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 |
22 | 00817274022856 | HDL4-250 | HDL4-250 | HDL CHOLESTEROL (4x 125mL R1, 4x 42mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
23 | 00817274022252 | HDL4-125 | HDL4-125 | HDL CHOLESTEROL (2x 125mL R1, 2x 42mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
24 | 00817274021705 | XL-HDL4-40 | HDL, CHOLESTEROL (4x 40mL R1, 2x 45mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
25 | 00817274021699 | HDL4-BUL | HDL CHOLESTEROL Bulk | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
26 | 00817274021682 | HDL4-30 | HDL CHOLESTEROL (2x 30mL R1, 2x 10mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
27 | 00817274021675 | DG-HDL4-30 | HDL CHOLESTEROL (2 x 30mL R1, 2 x 10mL R2, 1 x 3mL Standard) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
28 | 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. |
29 | 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. |
30 | 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. |
31 | 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. |
32 | 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. |
33 | 00630414610832 | 11537213 | 11537213 | HDL Cholesterol (HDLC) Atellica CH Assay 1792 Tests | Atellica CH HDLC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
34 | 00630414596204 | 11097630 | 11097630 | Direct HDL Cholesterol (D-HDL) Atellica™ CH - RGT 1792T | Atellica™ CH D-HDL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
35 | 00630414551784 | 10283089 | 6521559 | HDL Cholesterol - ADVIA Chem. - RGT - 6x670 tests | ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
36 | 00630414508436 | 10309507 | 7511947 | HDL Cholesterol - ADVIA Chem. - RGT - 4x326 tests | ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
37 | 00628063400614 | SK6122-20 | SK6122-20 | HDL Ultra Cholesterol Reagent | SEKISUI DIAGNOSTICS, LLC | |
38 | 00628063400591 | 80-6283-00 | 80-6283-00 | Ultra N-geneous HDL Cholesterol Reagent | SEKISUI DIAGNOSTICS, LLC | |
39 | 00628063400584 | 80-6277-00 | 80-6277-00 | Ultra N-geneous HDL Cholesterol Reagent | SEKISUI DIAGNOSTICS, LLC | |
40 | 00628063400553 | 6122 | 6122 | HDL Ultra Cholesterol | SEKISUI DIAGNOSTICS, LLC | |
41 | 00628063400546 | 6121 | 6121 | HDL Ultra Cholesterol | SEKISUI DIAGNOSTICS, LLC | |
42 | 00386100002077 | 10211-4 | 10211-4 | HDL Cholesterol Reagent Kit for use with EasyRA Analyzers | HDL CHOL Reagent Kit | MEDICA CORPORATION |
43 | 00380740161484 | 3K33-22 | 03K3322 | Ultra HDL | ARCHITECT | ABBOTT GMBH |
44 | 00380740129996 | 07P7530 | 07P7530 | Alinity c Ultra HDL Reagent Kit 3500 Tests | Alinity | ABBOTT GMBH |
45 | 00380740129989 | 07P7520 | 07P7520 | Alinity c Ultra HDL Reagent Kit 1400 Tests | Alinity | ABBOTT GMBH |
46 | 00380740005313 | 3K33-21 | 03K3321 | Ultra HDL | ARCHITECT | ABBOTT LABORATORIES |
47 | B3959930030 | 9930030 | 9930030 | NMR Reference Standard used for the Vantera Clinical Analyzer. | NMR Reference Standard | LABCORP OF AMERICA |
48 | B3959920030 | 9920030 | 9920030 | Sample Diluent 1 used for the Vantera Clinical Analyzer. | NMR Diluent 1 | LABCORP OF AMERICA |
49 | B3959910030 | 9910030 | 9910030 | WASH Solution used for the Vantera Clinical Analyzer | NMR WASH Solution | LABCORP OF AMERICA |
50 | B3959900300 | 9900300 | 9900300 | Clinical Analyzer | Vantera Clinical Analyzer | LABCORP OF AMERICA |