No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00857969006709 | 404200-1 | 404200-1 | ACE Axcel Clinical Chemistry System with ISE | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ACE Axcel® |
2 | 00857969006600 | S2-87 | S2-87 | Hemoglobin A1c Calibrators | JIS | Calibrator, Primary | 2 | Alfa Wassermann |
3 | 00857969006433 | C2-87 | C2-87 | Lipid Controls | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alfa Wassermann |
4 | 00857969006426 | C2-86 | C2-86 | Hemoglobin A1c Controls | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Alfa Wassermann |
5 | 00857969006402 | C1-5 | C1-5 | Level 2 Chemistry Control | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alfa Wassermann |
6 | 00857969006396 | C1-4 | Level 1 Chemistry Control | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alfa Wassermann | |
7 | 00857969006389 | SA1029 | SA1029 | CAL A | JIX | Calibrator, Multi-Analyte Mixture | 2 | Alfa Wassermann |
8 | 00857969006372 | E1-9 | E1-9 | STARLYTE V Fluid Pack | Alfa Wassermann | |||
9 | 00857969006327 | E1-3 | E1-3 | REFERENCE ELECTRODE SOLUTION | Alfa Wassermann | |||
10 | 00857969006310 | E1-2 | E1-2 | CAL B | Alfa Wassermann | |||
11 | 00857969006204 | S2-86 | S2-86 | Hemoglobin A1c Calibrators | JIS | Calibrator, Primary | 2 | Alfa Wassermann |
12 | 00857969006198 | S2-85 | S2-85 | Urine Standard | JIX | Calibrator, Multi-Analyte Mixture | 2 | Alfa Wassermann |
13 | 00857969006181 | S1-33 | S1-33 | GemCal Reference Serum | JIX | Calibrator, Multi-Analyte Mixture | 2 | Alfa Wassermann |
14 | 00857969006051 | 906178 | 906178 | Electrode, Chloride | CGZ | Electrode, Ion-Specific, Chloride | 2 | Alfa Wassermann |
15 | 00857969006044 | 903394 | 903394 | Electrode, Potassium | CEM | Electrode, Ion Specific, Potassium | 2 | Alfa Wassermann |
16 | 00857969006037 | 903393 | 903393 | Electrode, Sodium | JGS | Electrode, Ion Specific, Sodium | 2 | Alfa Wassermann |
17 | 00857969006693 | 402900-1 | 402900-1 | ACE Alera Clinical Chemistry System with ISE | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ACE Alera® |
18 | 00857969006587 | SA2019 | SA2019 | Magnesium Reagent | JGJ | Photometric Method, Magnesium | 1 | ACE |
19 | 00857969006594 | SA2038 | SA2038 | HDL-C Reagent | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | ACE |
20 | 00857969006686 | RX1053 | RX1053 | AST Reagent | CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | ACE |
21 | 00857969006679 | SA1053 | SA1053 | AST Reagent | CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | ACE |
22 | 00857969006662 | SA1052 | SA1052 | ALT Reagent | CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | ACE |
23 | 00857969006655 | SA1028 | SA1028 | ISE CLEANING AND SODIUM ELECTRODE CONDITIONER | ACE | |||
24 | 00857969006648 | SA1027 | SA1027 | ISE WASH | ACE | |||
25 | 00857969006631 | SA1021 | SA1021 | SYSTEM DILUENT | ACE | |||
26 | 00857969006624 | SA1020 | SA1020 | NORMAL SALINE DILUENT | ACE | |||
27 | 00857969006617 | SA1050 | SA1050 | Hemoglobin A1c Reagent | LCP | Assay, Glycosylated Hemoglobin | 2 | ACE |
28 | 00857969006570 | SA2016 | SA2016 | Inorganic Phosphorus U.V. Reagent | CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | ACE |
29 | 00857969006563 | SA2013 | SA2013 | γ-GT Reagent | JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 | ACE |
30 | 00857969006556 | SA1046 | SA1046 | ALT Reagent | CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | ACE |
31 | 00857969006549 | SA1045 | SA1045 | Lipase Reagent | CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 | ACE |
32 | 00857969006532 | SA1043 | SA1043 | HDL-C Reagent | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | ACE |
33 | 00857969006525 | SA1040 | SA1040 | LDL-C Reagent | MRR | System, Test, Low Density, Lipoprotein | 1 | ACE |
34 | 00857969006518 | SA1025 | SA1025 | Uric Acid Reagent | KNK | Acid, Uric, Uricase (Colorimetric) | 1 | ACE |
35 | 00857969006501 | SA1023 | SA1023 | Triglycerides Reagent | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | ACE |
36 | 00857969006495 | SA1017 | SA1017 | Total Iron Reagent | JIY | Photometric Method, Iron (Non-Heme) | 1 | ACE |
37 | 00857969006488 | SA1010 | SA1010 | Cholesterol Reagent | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | ACE |
38 | 00857969006471 | RX1026 | RX1026 | LDL-C Reagent | MRR | System, Test, Low Density, Lipoprotein | 1 | ACE |
39 | 00857969006457 | RX1023 | RX1023 | Triglycerides Reagent | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | ACE |
40 | 00857969006440 | RX1010 | RX1010 | Cholesterol Reagent | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | ACE |
41 | 00857969006419 | C2-85 | C2-85 | Urine Chemistry Controls | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | ACE |
42 | 00857969006365 | E1-8 | E1-8 | Starlyte III Fluid Pack | ACE | |||
43 | 00857969006358 | E1-7 | E1-7 | Urine Diluent | ACE | |||
44 | 00857969006341 | E1-6 | E1-6 | Starlyte Sodium Electrode Conditioner | ACE | |||
45 | 00857969006334 | E1-5 | E1-5 | Starlyte Cleaning Solution | ACE | |||
46 | 00857969006303 | SA2002 | SA2002 | Alkaline Phosphatase Reagent | CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | ACE |
47 | 00857969006297 | RX2002 | RX2002 | Alkaline Phosphatase Reagent | CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | ACE |
48 | 00857969006280 | SA3018 | SA3018 | LDH-L Reagent | CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | ACE |
49 | 00857969006273 | SA3007 | SA3007 | T4 Reagent | KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | ACE |
50 | 00857969006266 | SA2024 | SA2024 | BUN / UREA Reagent | CDN | Urease, Photometric, Urea Nitrogen | 2 | ACE |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00657498001608 | S1045-750 | S1045-750 | For the Quantitative Colorimetric Determination of Uric Acid in Serum, Plasma or Urine. | Sirrus® Uric Acid LiquiColor® | STANBIO LABORATORY, L.P. |
2 | 00657498001110 | 1045-225 | 1045-225 | Quantitative Enzymatic Colorimetric Determination of Uric Acid in Serum, Plasma or Urine. | Uric Acid LiquiColor® | STANBIO LABORATORY, L.P. |
3 | 00657498001103 | 1045-430 | 1045-430 | Quantitative Enzymatic Colorimetric Determination of Uric Acid in Serum, Plasma or Urine. | Uric Acid LiquiColor® | STANBIO LABORATORY, L.P. |
4 | 00630414596334 | 11097608 | 11097608 | Uric Acid (UA) Atellica CH - RGT 4800T | Atellica CH UA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00630414526737 | 10335873 | 4993452 | Uric Acid - ADVIA Chem. - RGT - 6x1250 tests | ADVIA® Chemistry UA_c Uric Acid Reagents, Concentrated | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00630414517650 | 10341133 | 3051305 | Uric Acid - ADVIA Chem. - RGT - 6x670 tests | ADVIA® Chemistry UA Uric Acid Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00630414508313 | 10309492 | 7497014 | Uric Acid - ADVIA Chem. - RGT - 7x140 tests | ADVIA® Chemistry UA Uric Acid Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
8 | 00628063401130 | SK237-40 | SK237-40 | Uric Acid Assay | SEKISUI DIAGNOSTICS, LLC | |
9 | 00628063401000 | 237-99 | 237-99 | URIC ACID-SL Assay | SEKISUI DIAGNOSTICS, LLC | |
10 | 00628063400997 | 237-60 | 237-60 | URIC ACID-SL Assay | SEKISUI DIAGNOSTICS, LLC | |
11 | 00386100002046 | 10208-4 | 10208-4 | Uric Acid Reagent Kit for use with EasyRA Analyzers | Uric Reagent Kit | MEDICA CORPORATION |
12 | 00380740161613 | 3P39-42 | 03P3942 | Uric Acid | ARCHITECT | ABBOTT GMBH |
13 | 00380740161606 | 3P39-22 | 03P3922 | Uric Acid | ARCHITECT | ABBOTT GMBH |
14 | 00380740158743 | 04U0930 | 04U0930 | Uric Acid2 2000 Tests | Alinity | ABBOTT IRELAND |
15 | 00380740158378 | 04U0920 | 04U0920 | Uric Acid2 640 Tests | Alinity | ABBOTT IRELAND |
16 | 00380740135270 | 08P5630 | 08P5630 | Alinity c Uric Acid Reagent Kit 5000 Tests | Alinity | ABBOTT GMBH |
17 | 00380740135263 | 08P5620 | 08P5620 | Alinity c Uric Acid Reagent Kit 1200 Tests | Alinity | ABBOTT GMBH |
18 | 00380740006747 | 3P39-21 | 03P3921 | Uric Acid | ARCHITECT | ABBOTT LABORATORIES |
19 | 15099590575281 | 442785 | 442785 | Uric Acid Reagent (URIC 2 x 300) | Synchron | BECKMAN COULTER, INC. |
20 | 15099590060152 | OSR6698 | Uric Acid | AU | BECKMAN COULTER, INC. | |
21 | 15099590020385 | OSR6298 | Uric Acid | AU | BECKMAN COULTER, INC. | |
22 | 15099590010942 | OSR6198 | Uric Acid | AU | BECKMAN COULTER, INC. | |
23 | 15099590000349 | OSR6098 | Uric Acid | AU | BECKMAN COULTER, INC. | |
24 | 10758750000340 | 1943927 | 1943927 | VITROS Chemistry Products URIC Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
25 | 08806141303077 | 31H0P | One+Step Uric Acid | DFI CO.,LTD | ||
26 | 07613336121580 | 08058750190 | 08058750190 | Uric Acid ver.2 | ROCHE DIAGNOSTICS GMBH | |
27 | 05060500091972 | IR460-1200 | IR460-1200 | Uric Acid Reagent 2 X 67 mL + 1 X 54 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
28 | 05060500091521 | IR462-L | IR462-L | Uric Acid Enzyme Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
29 | 05060500091514 | IR461-L | IR461-L | Uric Acid Chromogen Reagent 6 X 1000 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
30 | 05060500091507 | IR460-911 | IR460-911 | Uric Acid Reagent 6 X 50 mL + 3 X 40 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
31 | 05060500091491 | IR460-WK | IR460-WK | Uric Acid Reagent 3 X 25 mL + 3 X 10 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
32 | 05060500091484 | IR460-X | IR460-X | Uric Acid Reagent 1 X 250 mL + 1 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
33 | 05060500091477 | IR460-R | IR460-R | Uric Acid Reagent 3 X 250 mL + 3 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
34 | 05055273209570 | UA8333 | URIC ACID (UA) | RANDOX LABORATORIES LIMITED | ||
35 | 05055273209563 | UA8069 | URIC ACID (UA) | RANDOX LABORATORIES LIMITED | ||
36 | 05055273206753 | UA7972 | URIC ACID (UA) | RANDOX LABORATORIES LIMITED | ||
37 | 04015630925124 | 5171857190 | 5171857190 | Uric Acid ver.2 | ROCHE DIAGNOSTICS GMBH | |
38 | 04015630922550 | 04657608190 | 04657608190 | Uric Acid ver.2 | ROCHE DIAGNOSTICS GMBH | |
39 | 04015630919154 | 3183807190 | 3183807190 | Uric Acid ver.2 | ROCHE DIAGNOSTICS GMBH | |
40 | 03610230007228 | 1300023870 | Yumizen C1200 Uric acid | HORIBA ABX SAS | ||
41 | 03610230005231 | 1220001670 | ABX PENTRA URIC ACID CP | HORIBA ABX SAS | ||
42 | EABA40000351 | 400-0035 | 400-0035 | The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry an The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo BioChemistry Panel Plus | ABAXIS, INC. |
43 | EABA40000291 | 400-0029 | 400-0029 | The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.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 may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo General Chemistry 13 | ABAXIS, INC. |
44 | 00857969006518 | SA1025 | SA1025 | Uric Acid Reagent | ACE | ALFA WASSERMANN, INC. |
45 | 00857969006464 | RX1025 | RX1025 | Uric Acid Reagent | ACE | ALFA WASSERMANN, INC. |
46 | 00852169008263 | URA1500 | URA1500 | In Vitro Diagnostics testing kit R1:5X30mL | ClearChem Diagnostics Inc. Uric Acid | CLEARCHEM DIAGNOSTICS INC. |
47 | 00842768015519 | 10445145 | K1077 | Uric Acid Flex® reagent cartridge, 560 tests | Dimension Vista® Flex® reagent cartridge URCA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00842768014192 | 10444967 | DF77 | Uric Acid Flex® reagent cartridge, 480 tests | Dimension® Flex® reagent cartridge URCA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00817439021366 | UA600 | UA600 | For the quantitative determination of Uric Acid in serum using the Mindray BS-20 For the quantitative determination of Uric Acid in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only. 3 x 40ml. | MedTest DX Uric Acid for the BS200 | MEDTEST DX, INC. |
50 | 00817439021342 | UA480 | UA480 | For the quantitative determination of Uric Acid in serum using the Mindray BS-48 For the quantitative determination of Uric Acid in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. 4 x 40ml. | MedTest DX Uric Acid for the BS480 | MEDTEST DX, INC. |