| 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 | 00628063400355 | 234-60 | 234-60 | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | CHOLESTEROL-SL | ||
| 3 | 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 | |
| 4 | 00628063400676 | 80-4598-00 | 80-4598-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R1) | |
| 5 | 00628063400669 | 7120 | 7120 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | LDL Direct LS Cholesterol Reagent Kit | |
| 6 | 00742860001017 | 101 | 101 | JHI | Visual, pregnancy hCG, prescription use | OSOM hCG Urine 50 Test Kit | ||
| 7 | 00628063400539 | SK235-10 | SK235-10 | CFR | HEXOKINASE, GLUCOSE | GLUCOSE | ||
| 8 | 00628063401154 | SK350-CAL | SK350-CAL | JIT | Calibrator, secondary | 2 | HbA1c Calibrators | |
| 9 | 00628063401116 | SK252-20 | SK252-20 | DCF | ALBUMIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Microalbumin | |
| 10 | 00628063400690 | 80-4604-00 | 80-4604-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R1) | |
| 11 | 00628063400652 | 327-30 | 327-30 | CFJ | NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE | 2 | LACTATE DEHRYDROGENASE-SL Assay | |
| 12 | 00628063400225 | SK284-20 | SK284-20 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Total Bilirubin | |
| 13 | 00628063400164 | 247-30 | 247-30 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | DIRECT BILIRUBIN-SL Assay | |
| 14 | 00628063400089 | 328-30 | 328-30 | CJE | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES | 2 | ALKALINE PHOSPHATASE-SL | |
| 15 | 00742860100161 | 175 | 175 | LYR | Helicobacter pylori | OSOM H Pylori 25 Test Kit | ||
| 16 | 00628063401086 | SK273-40 | SK273-40 | DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | 2 | Ethanol Assay | |
| 17 | 00742860001475 | 147 | 147 | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | OSOM Ultra Strep A 25 Test Kit | ||
| 18 | 00628063400867 | 511-40 | 511-40 | DKJ | COLORIMETRY, SALICYLATE | 2 | SALICYLATE-SL Assay | |
| 19 | 00628063400850 | SK117-20 | SK117-20 | CEO | Phosphomolybdate (colorimetric), inorganic phosphorus | 1 | PHOSPHORUS | |
| 20 | 00628063400799 | 175-12 | 175-12 | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | MAGNESIUM Reagent | ||
| 21 | 00742860001024 | 102W | 102W | JHI | Visual, pregnancy hCG, prescription use | OSOM hCG Card 25 Test Kit | ||
| 22 | 00742860100093 | 138 | 138 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HCG SERUM CONTROL KIT | |
| 23 | 00628063401178 | SK350-BLK | SK350-BLK | JIT | Calibrator, secondary | HbA1c Blank Solution | ||
| 24 | 00628063401161 | SK350-QC | SK350-QC | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HbA1c Controls | |
| 25 | 00628063401147 | SK350-60 | SK350-60 | PDJ,LCP | Hemoglobin A1c test system,ASSAY, GLYCOSYLATED HEMOGLOBIN | 2 | HbA1c Assay | |
| 26 | 00628063400454 | SM-052 | SM-052 | JJY | Multi-analyte controls, all kinds (assayed) | DC-TROL Level 1 | ||
| 27 | 00628063400430 | 250-20 | 250-20 | DCK | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | 2 | Wide Range CRP Assay | |
| 28 | 00628063400140 | 319-30 | 319-30 | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | AST-SL | |
| 29 | 00628063400072 | SK200-10 | SK200-10 | CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN | ALBUMIN | ||
| 30 | 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 | |
| 31 | 00742860100147 | 191 | 191 | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | OSOM Influenza Control Kit | ||
| 32 | 00742860001499 | 149 | 149 | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | OSOM Ultra Strep A 50 Test Kit | ||
| 33 | 00742860100178 | 176 | 176 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | OSOM H. Pylori Control Kit | |
| 34 | 00742860001451 | 145 | 145 | KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | OSOM Mono 25 Test Kit | ||
| 35 | 00628063400935 | 153-90 | 153-90 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
| 36 | 00628063400928 | 153-10 | 153-10 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
| 37 | 00742860100048 | 755725 | 755725 | KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | MONO, MERIDIAN IMMUNO 25 Test Kit | ||
| 38 | 00628063400980 | SK283-10 | SK283-10 | CDQ | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN | UREA | ||
| 39 | 00628063400959 | 153-50 | 153-50 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
| 40 | 00628063400942 | 153-30 | 153-30 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
| 41 | 00628063400904 | 236-99 | 236-99 | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | 1 | TRIGLYCERIDE-SL | |
| 42 | 00628063400898 | 236-60 | 236-60 | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | TRIGLYCERIDE-SL | ||
| 43 | 00628063400836 | SE-252 | SE-252 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | MICROALBUMIN Calibrators | |
| 44 | 00628063400744 | 80-5666-02 | 80-5666-02 | JIS | CALIBRATOR, PRIMARY | N-geneous LDL-ST Cholesterol Calibrator | ||
| 45 | 00628063400492 | 273-30 | 273-30 | DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | 2 | ETHANOL L3K Assasy | |
| 46 | 00742860100406 | 1034 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | OSOM ULTRA PLUS FLU A&B Control Kit | ||
| 47 | 00742860100345 | 1031 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | Acucy Calibration Device | ||
| 48 | 00628063400805 | 450-50 | 450-50 | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | TOTAL PROTEIN (MICRO) Assay | |
| 49 | 00628063400706 | 80-4607-00 | 80-4607-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R2) | |
| 50 | 00628063401130 | SK237-40 | SK237-40 | KNK | Acid, uric, uricase (colorimetric) | Uric Acid Assay |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 05060500091859 | IR060-1200 | IR060-1200 | Cholesterol Reagent 6 X 67 mL + 3 X 54 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 2 | 05060500090623 | IR062-L | IR062-L | Cholesterol Enzyme Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 3 | 05060500090616 | IR061-L | IR061-L | Cholesterol Chromogen Reagent 6 X 1000 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 4 | 05060500090609 | IR060-911 | IR060-911 | Cholesterol Reagent 6 X 50 mL + 3 X 40 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 5 | 05060500090593 | IR060-WK | IR060-WK | Cholesterol Reagent 3 X 25 mL + 3 X 10 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 6 | 05060500090586 | IR060-X | IR060-X | Cholesterol Reagent 1 X 250 mL + 1 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 7 | 05060500090579 | IR060-R | IR060-R | Cholesterol Reagent 3 X 250 mL + 3 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 8 | 05055273208474 | CH8310 | For the quantitative in vitro determination of cholesterol in serum and plasma. | CHOLESTEROL (CHOL) | RANDOX LABORATORIES LIMITED | |
| 9 | 05055273208443 | CH8019 | CHOLESTEROL (CHOL) | RANDOX LABORATORIES LIMITED | ||
| 10 | 05055273201284 | CH3810 | CH3810 | For the quantitative in vitro determination of cholesterol in serum and plasma. | CHOL | RANDOX LABORATORIES LIMITED |
| 11 | 04571226470831 | 14-531 | 14-531 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 12 | 04015630924967 | 05168538190 | 05168538190 | Cholesterol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 13 | 04015630922062 | 04718917190 | 04718917190 | Cholesterol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 14 | 04015630918430 | 3039773190 | 03039773190 | Cholesterol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 15 | 03610230006917 | 1300023838 | Yumizen C1200 Cholesterol | HORIBA ABX SAS | ||
| 16 | 03610230004975 | 1220001634 | ABX PENTRA CHOLESTEROL CP | HORIBA ABX SAS | ||
| 17 | 00899722002344 | 99021 | 99021 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 18 | 00899722002337 | 99020 | 99020 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 19 | 00893038002654 | 10-991 | 10-991 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 20 | 00893038002647 | 10-990 | 10-990 | Alere Cholestech LDX® TC●HDL●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 21 | 00893038002630 | 10-989 | 10-989 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 22 | 00893038002623 | 10-988 | 10-988 | Alere Cholestech LDX® TC●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 23 | 00893038002616 | 10-987 | 10-987 | Alere Cholestech LDX® TC●HDL | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 24 | 00893038002609 | 10-986 | 10-986 | Alere Cholestech LDX® TC | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 25 | 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. |
| 26 | 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. |
| 27 | 00860394001256 | CURO L5 Total Cholesterol Strips | Total Cholesterol Strips | CURO L5 Total Cholesterol Strips | KPI HEALTHCARE, INC. | |
| 28 | 00860394001225 | CURO L5 CURO L5 | CURO L5 Cholesterol and Glucose measuring system | CURO L5 | KPI HEALTHCARE, INC. | |
| 29 | 00857969006488 | SA1010 | SA1010 | Cholesterol Reagent | ACE | ALFA WASSERMANN, INC. |
| 30 | 00857969006440 | RX1010 | RX1010 | Cholesterol Reagent | ACE | ALFA WASSERMANN, INC. |
| 31 | 00852169008157 | CHL1100 | CHL1100 | In Vitro Diagnostics testing kit R1:4X60mL | ClearChem Diagnostics Inc. Cholesterol, Total | CLEARCHEM DIAGNOSTICS INC. |
| 32 | 00850014861346 | TD-4289 | HeartsCare C1 Total Cholesterol Test Strip (10pcs/box) | HEARTS BIO, INC. | ||
| 33 | 00850006113064 | Curo L5 | CURO L5 Glucose Strip | Curo L5 | KPI HEALTHCARE, INC. | |
| 34 | 00842768015090 | 10445143 | K1027 | Cholesterol Flex® reagent cartridge, 600 tests | Dimension Vista® Flex® reagent cartridge CHOL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 35 | 00842768005466 | 10444891 | DF27 | Cholesterol Flex® reagent cartridge, 480 tests | Dimension® Flex® reagent cartridge CHOL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 36 | 00817302024548 | ST211 | ST211 | Cholesterol (CHOL) Reagent | CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT ST211 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 37 | 00817302024401 | DT211 | DT211 | Cholesterol (CHOL) Reagent | CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT DT211 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 38 | 00817302024166 | BL211 | BL211 | Cholesterol (CHOL) | CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT BL211 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 39 | 00817302024067 | AU-211 | AU-211 | Cholesterol | CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT AU-211 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 40 | 00817302022360 | CC211 | CC211 | CHOL (Cholesterol) 2 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CHOL CHOLESTEROL REAGENT CC211 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 41 | 00817274021255 | CHO2-BUP | CHOLESTEROL PALS BULK (in 20 dry Liter bottles) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 42 | 00817274021248 | CHO2-1L | CHOLESTEROL LIQUID REAGENT (1x 1L) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 43 | 00817274021224 | CHO2-1LU | Cholesterol Liquid (1x 1L) UV | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 44 | 00817274021217 | CHO2-125U | CHOLESTEROL LIQUID (1x 125mL) UV | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 45 | 00817274021200 | DG-CHO2-1L | CHOLESTEROL LIQUID (1 x 1 Liter + 1 x 5 mL Standard) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 46 | 00817274021194 | XL-CHO2-40 | CHOLESTEROL LIQ (5 x 40mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 47 | 00817274021187 | CHO2-125 | CHOLESTEROL LIQ (2x 125mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 48 | 00812137011930 | 500mL | 501-406 | For the quantitative determination of Total Cholesterol in serum. | Cholesterol Reagent | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 49 | 00811727016089 | 16-C7510-520 | 16-C7510-520 | Pointe Cholesterol Reagent packaged for use on the Mindray BA800. 8 x 65ml. Pointe Cholesterol Reagent packaged for use on the Mindray BA800. 8 x 65ml. For the quantitative determination of Total Cholesterol in serum. | Pointe Cholesterol Reagent | POINTE SCIENTIFIC, INC. |
| 50 | 00811727015778 | 14-C7510-480 | 14-C7510-480 | Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the qu Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the quantitative determination of Total Cholesterol in serum. For in vitro diagnostic use. | Pointe Cholesterol on BS480 | POINTE SCIENTIFIC, INC. |