No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00380740200053 | 08P433C | 08P433C | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
2 | 00380740200060 | 09P271B | 09P271B | Alinity i Anti-CCP Assay File | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Alinity |
3 | 00380740200046 | 08P435C | 08P435C | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
4 | 00380740200039 | 08P431C | 08P431C | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
5 | 00380740200022 | 08P437C | 08P437C | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
6 | 00380740199487 | 04V511B | 04V511B | Alinity c Total Bilirubin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
7 | 00380740195458 | 07P701C | 07P701C | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
8 | 00380740195380 | 08P181B | 08P181B | Alinity c A-ALT Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
9 | 00380740194208 | 09P523B | 09P523B | Alinity c BenzSQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
10 | 00380740194192 | 09P521B | 09P521B | Alinity c BenzQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
11 | 00380740194093 | 06S611A | 06S611A | Alinity i COV 2IgGII Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
12 | 00380740193638 | 04Z211A | 04Z211A | Alinity i STAT High Sensitivity Tropopnin-I | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
13 | 00380740193577 | 07P701B | 07P701B | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
14 | 00380740192723 | 04U093A | 04U093A | Alinity c Uric2-U Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
15 | 00380740192464 | 06R911A | 06R911A | Alinity i COV-2 IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
16 | 00380740189105 | 08P013B | 08P013B | Alinity c CrEnzU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
17 | 00380740189099 | 08P011B | 08P011B | Alinity c CrEnz Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
18 | 00380740186418 | 04T843A | 04T843A | Alinity c ALT2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
19 | 00380740186401 | 04T841A | 04T841A | Alinity c ALT2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
20 | 00380740186395 | 04T863A | 04T863A | Alinity c AST2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
21 | 00380740186388 | 04T861A | 04T861A | Alinity c AST2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
22 | 00380740186364 | 04U091A | 04U091A | Alinity c Uric2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
23 | 00380740186265 | 04T961A | 04T961A | Alinity c GGT2 Asasy File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
24 | 00380740186159 | 04T811A | 04T811A | Alinity c TPRO2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
25 | 00380740185978 | 07P569A | 07P569A | Alinity c CardiacCRP Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
26 | 00380740185787 | 09P261B | 09P261B | Alinity i Active B12 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
27 | 00380740181000 | 09P533A | 09P533A | Alinity c SerBENZQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
28 | 00380740180201 | 08P433B | 08P433B | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
29 | 00380740180195 | 08P435B | 08P435B | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
30 | 00380740180188 | 08P431B | 08P431B | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
31 | 00380740180171 | 08P437B | 08P437B | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
32 | 00380740180164 | 08P541B | 08P541B | Alinity c Phenytoin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
33 | 00380740180157 | 08P591B | 08P591B | Alinity c Salicylate Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
34 | 00380740180140 | 08P193C | 08P193C | Alinity c MagnesiumU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
35 | 00380740180133 | 08P191C | 08P191C | Alinity c Magnesium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
36 | 00380740180126 | 09P631B | 09P631B | Alinity c IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
37 | 00380740180119 | 08P531D | 08P531D | Alinity c Lithium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
38 | 00380740180089 | 08P041B | 08P041B | Alinity c Microalb Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
39 | 00380740180058 | 08P551B | 08P551B | Alinity c Gentamicin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
40 | 00380740180041 | 09P931B | 09P931B | Alinity c Cerulo Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
41 | 00380740180034 | 07P591B | 07P591B | Alinity c U/CSF Prot Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
42 | 00380740180027 | 07P751B | 07P751B | Alinity c Ultra HDL Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
43 | 00380740180010 | 07P771B | 07P771B | Alinity c Trig Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
44 | 00380740180003 | 09P861B | 09P861B | Alinity c Prealbumin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
45 | 00380740179991 | 07P761B | 07P761B | Alinity c Chol Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
46 | 00380740179984 | 08P021B | 08P021B | Alinity c AlbuminBCG Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
47 | 00380740179977 | 07P691C | 07P691C | Alinity i Free T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
48 | 00380740179960 | 07P941C | 07P941C | Alinity i Total T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
49 | 00380740179571 | 07P567A | 07P567A | Alinity c CRP WR Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
50 | 00380740179564 | 07P565A | 07P565A | Alinity c CRP HS Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00657498001479 | S0190-750 | S0190-750 | For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma. | Sirrus® Bicarbonate (CO2) LiquiColor® | STANBIO LABORATORY, L.P. |
2 | 00630414595900 | 11097521 | 11097521 | Carbon dioxide (CO2_c) Atellica CH - RGT 7600T | Atellica CH CO2_c | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
3 | 00630414553177 | 10283345 | 6860507 | CO2 enzymatic - ADVIA Chem. - Conc. RGT - 7520 tests | ADVIA® Chemistry CO2_c Reagents Concentrated | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
4 | 00630414505497 | 10326480 | 7506781 | CO2 enzymatic - ADVIA Chem. - RGT - 1200 tests | ADVIA® Chemistry CO2_L Carbon Dioxide Liquid Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00630414498928 | 10327377 | 7987100 | CO2 enzymatic - ADVIA Chem. - RGT - 4x600 tests | ADVIA® Chemistry CO2_L Reagents (Liquid) | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00630414000541 | 10720780 | 10720780 | ADVIA Chemistry CO2_c 20mL | ADVIA Chemistry CO2_c | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00628063400348 | 288-80 | 288-80 | CARBON DIOXIDE L3K-C Assay | SEKISUI DIAGNOSTICS, LLC | |
8 | 00628063400331 | 288-36 | 288-36 | CARBON DIOXIDE L3K-C Assay | SEKISUI DIAGNOSTICS, LLC | |
9 | 00628063400324 | SK299-10 | SK299-10 | CARBON DIOXIDE | SEKISUI DIAGNOSTICS, LLC | |
10 | 00628063400317 | 299-80 | 299-80 | CARBON DIOXIDE L3K Assay | SEKISUI DIAGNOSTICS, LLC | |
11 | 00628063400300 | 299-55 | 299-55 | CARBON DIOXIDE L3K Assay | SEKISUI DIAGNOSTICS, LLC | |
12 | 00628063400294 | 299-30 | 299-30 | CARBON DIOXIDE L3K Assay | SEKISUI DIAGNOSTICS, LLC | |
13 | 00628063400287 | 299-17 | 299-17 | CARBON DIOXIDE L3K Assay | SEKISUI DIAGNOSTICS, LLC | |
14 | 00628063400003 | 299-50 | 299-50 | Carbon Dioxide L3K | SEKISUI DIAGNOSTICS, LLC | |
15 | 00386100002053 | 10209-4 | 10209-4 | Carbon dioxide Reagent Kit for use with EasyRA Analyzers | CO2 Reagent Kit | MEDICA CORPORATION |
16 | 00380740161545 | 3L80-42 | 03L8042 | Carbon Dioxide | ARCHITECT | ABBOTT GMBH |
17 | 00380740161538 | 3L80-32 | 03L8032 | Carbon Dioxide | ARCHITECT | ABBOTT GMBH |
18 | 00380740161521 | 3L80-22 | 03L8022 | Carbon Dioxide | ARCHITECT | ABBOTT GMBH |
19 | 00380740121600 | 07P7230 | 07P7230 | Alinity c Carbon Dioxide Reagent Kit 15000 Tests | Alinity | ABBOTT GMBH |
20 | 00380740121594 | 07P7220 | 07P7220 | Alinity c Carbon Dioxide Reagent Kit 3000 Tests | Alinity | ABBOTT GMBH |
21 | 00380740005962 | 3L80-31 | 03L8031 | Carbon Dioxide | ARCHITECT | ABBOTT LABORATORIES |
22 | 00380740005955 | 3L80-21 | 03L8021 | Carbon Dioxide | ARCHITECT | ABBOTT LABORATORIES |
23 | 15099590625726 | A60290 | A60290 | Enzymatic Carbon Dioxide (CO2E 2 x 300) | Synchron | BECKMAN COULTER, INC. |
24 | 15099590060206 | OSR6637 | Bicarbonate | AU | BECKMAN COULTER, INC. | |
25 | 15099590020187 | OSR6237 | Bicarbonate | AU | BECKMAN COULTER, INC. | |
26 | 15099590010348 | OSR6137 | Bicarbonate | AU | BECKMAN COULTER, INC. | |
27 | 10758750004645 | 8262396 | 8262396 | VITROS Chemistry Products ECO2 Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
28 | 07613336121146 | 08057494190 | 08057494190 | Bicarbonate Liquid | ROCHE DIAGNOSTICS GMBH | |
29 | 05060500090654 | UV380-WK | UV380-WK | CO2 Reagent 3 X 50 mL + 3 powder wedges | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
30 | 05060500090647 | UV380-X | UV380-X | CO2 Reagent 1 X 250 mL + 1 X powder vial | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
31 | 05060500090630 | UV380-R | UV380-R | CO2 Reagent 3 X 250 mL + 3 powder vials | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
32 | 05055273213959 | CD8357 | CD8357 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | LCO2-2 | RANDOX LABORATORIES LIMITED |
33 | 05055273208375 | CD4006 | CD4006 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | LCO2-2 | RANDOX LABORATORIES LIMITED |
34 | 05055273201086 | CD7942 | CD7942 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | CO2 | RANDOX LABORATORIES LIMITED |
35 | 05055273201031 | CD129 | CD129 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | CO2 | RANDOX LABORATORIES LIMITED |
36 | 05055273201024 | CD127 | CD127 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | CO2 | RANDOX LABORATORIES LIMITED |
37 | 05055273201017 | CD116 | CD116 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | CO2 | RANDOX LABORATORIES LIMITED |
38 | 04015630997237 | 3607402190 | 3607402190 | Bircarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
39 | 04015630935673 | 5446376191 | 5446376191 | BicarbonateBicarbonate STAT | ROCHE DIAGNOSTICS GMBH | |
40 | 04015630927395 | 5455308190 | 5455308190 | Bircarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
41 | 04015630919376 | 3289885190 | 3289885190 | Bicarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
42 | 04015630919369 | 3289907190 | 3289907190 | Bicarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
43 | 04015630919352 | 3289923190 | 3289923190 | Bicarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
44 | 03610230006863 | 1300023833 | Yumizen C1200 CO2 | HORIBA ABX SAS | ||
45 | 03610230005071 | 1220001645 | ABX PENTRA CO2 RTU | HORIBA ABX SAS | ||
46 | EABA40000371 | 400-0037 | 400-0037 | The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. | Piccolo MetLac 12 Panel | ABAXIS, INC. |
47 | EABA40000341 | 400-0034 | 400-0034 | The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemis The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) 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 MetLyte Plus CRP | ABAXIS, INC. |
48 | EABA40000311 | 400-0031 | 400-0031 | The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry a The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only. | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. |
49 | EABA40000281 | 400-0028 | 400-0028 | The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemist The Piccolo® Comprehensive Metabolic Panel, 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), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) 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 Comprehensive Metabolic Panel | ABAXIS, INC. |
50 | EABA40000271 | 400-0027 | 400-0027 | The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyz The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) 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 Renal Function Panel | ABAXIS, INC. |