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 | 07613336120989 | 08056773190 | 08056773190 | Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation | ROCHE DIAGNOSTICS GMBH | |
2 | 05060500091712 | UV185-1200 | UV185-1200 | ALT Reagent 8 X 67 mL + 2 X 67 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
3 | 05060500090227 | UV182-L | UV182-L | ALT Starter Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
4 | 05060500090210 | UV184-L | UV184-L | ALT Substrate Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
5 | 05060500090203 | UV185-911 | UV185-911 | ALT Reagent 4 X 50 mL + 1 X 50 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
6 | 05060500090197 | UV185-WK | UV185-WK | ALT Reagent 4 X 25 mL + 4 X 6.25 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
7 | 05060500090180 | UV185-X | UV185-X | ALT Reagent 1 X 100 mL + 1 X 25 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
8 | 05060500090173 | UV185-R | UV185-R | ALT Reagent 4 X 100 mL + 1 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
9 | 05055273208160 | AL8304 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | ||
10 | 05055273208153 | AL8006 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | ||
11 | 05055273200249 | AL7930 | AL7930 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
12 | 05055273200232 | AL7904 | AL7904 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
13 | 05055273200225 | AL3875 | AL3875 | An ALT test system is a device intended for the quantitative in vitro determinat An ALT test system is a device intended for the quantitative in vitro determination of of Alanine Aminotransferase (ALT) activity in serum and plasma. | ALT | RANDOX LABORATORIES LIMITED |
14 | 05055273200218 | AL3801 | AL3801 | An ALT test system is a device intended for the quantitative in vitro determinat An ALT test system is a device intended for the quantitative in vitro determination of Alanine Aminotransferase (ALT) activity in serum and plasma. | ALT | RANDOX LABORATORIES LIMITED |
15 | 05055273200195 | AL2360 | AL2360 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
16 | 05055273200188 | AL146 | AL146 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
17 | 05055273200171 | AL1268 | AL1268 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
18 | 05055273200164 | AL1205 | AL1205 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
19 | 05055273200157 | AL1200 | AL1200 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
20 | 05055273200133 | AL100 | AL100 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
21 | 04015630928927 | 5850797190 | 5850797190 | Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation | ROCHE DIAGNOSTICS GMBH | |
22 | 04015630927425 | 5531462190 | 5531462190 | Alanine Aminotransferase / Aspartate Aminotransferase acc. to IFCC with PYP | ROCHE DIAGNOSTICS GMBH | |
23 | 04015630921973 | 4718569190 | 4718569190 | Alanine aminotransferase acc. IFCC with or without PYP | ROCHE DIAGNOSTICS GMBH | |
24 | 04015630920532 | 4467388190 | 4467388190 | Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation | ROCHE DIAGNOSTICS GMBH | |
25 | 04015630913862 | 20764957322 | 20764957322 | Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation | ROCHE DIAGNOSTICS GMBH | |
26 | 03610230006856 | 1300023832 | Yumizen C1200 AST | HORIBA ABX SAS | ||
27 | 03610230006801 | 1300023797 | Yumizen C1200 ALT | HORIBA ABX SAS | ||
28 | 03610230004906 | 1220001627 | ABX PENTRA ALT CP | HORIBA ABX SAS | ||
29 | EABA40000411 | 400-0041 | 400-0041 | The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin 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 AmLyte 13 | ABAXIS, INC. |
30 | 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. |
31 | 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. |
32 | 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. |
33 | 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. |
34 | EABA40000261 | 400-0026 | 400-0026 | The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry ana The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitroquantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, directbilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratorysetting or point-of-care location. | Piccolo Hepatic Function Panel | ABAXIS, INC. |
35 | EABA40000061 | 400-0006 | 400-0006 | The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyz The Piccolo® General Chemistry 6 , 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), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, 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 General Chemistry 6 | ABAXIS, INC. |
36 | EABA40000031 | 400-0003 | 400-0003 | The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, utilizes dry and liquid reagents to provide in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin, and total protein 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 Liver Panel Plus | ABAXIS, INC. |
37 | 00857969006662 | SA1052 | SA1052 | ALT Reagent | ACE | ALFA WASSERMANN, INC. |
38 | 00857969006556 | SA1046 | SA1046 | ALT Reagent | ACE | ALFA WASSERMANN, INC. |
39 | 00852169008034 | ALT1020 | ALT1020 | In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL | ClearChem Diagnostics Inc. Alanine aminotransferase (ALT) | CLEARCHEM DIAGNOSTICS INC. |
40 | 00842768034336 | 10475530 | DF143 | Alanine Aminotransferase Flex® reagent cartridge, 240 tests | Dimension® Flex® reagent cartridge ALTI | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
41 | 00842768034312 | 10635565 | K2143 | Alanine Aminotransferase Flex® reagent cartridge, 480 tests | Dimension Vista® Flex® reagent cartridge ALTI | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
42 | 00842768000102 | 10444870 | 790035901 | Enzyme Diluent, 10x10mL | Dimension® Dimension Vista® System Enzyme Diluent | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
43 | 00817439020178 | ALT600 | ALT600 | For the quantitative determination of Alanine Aminotransferase (ALT) in serum us For the quantitative determination of Alanine Aminotransferase (ALT) in serum using the Mindray BS-200 analyzer.2 x 40 ml, 2 x 10 ml | ALT / BS200 | MEDTEST DX, INC. |
44 | 00817439020161 | ALT505 | ALT505 | For the quantitative in vitro determination of Alanine Aminotransferase (ALT) in For the quantitative in vitro determination of Alanine Aminotransferase (ALT) in serum and plasma.6 x 51 ml, 6 x 14 ml | ALT Reagent | MEDTEST DX, INC. |
45 | 00817439020154 | ALT480 | ALT480 | For the quantitative determination of alkaline phosphatase in human serum using For the quantitative determination of alkaline phosphatase in human serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device.5 x 60 ml, 5 x 15 ml. | ALT / BS480 | MEDTEST DX, INC. |
46 | 00817302024647 | AU-240 | AU-240 | Alkaline Aminotransferase (ALT) (GPT) Reagent | CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
47 | 00817302024593 | ST240 | ST240 | Alanine Aminotransferase (ALT) (GPT) Reagent | CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT ST240 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
48 | 00817302024456 | DT240 | DT240 | Alanine Aminotransferase (ALT) (GPT) Reagent | CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT DT240 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
49 | 00817302024296 | CC240 | CC240 | Alanine Aminotransferase Reagent (ALT) | CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT CC240 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
50 | 00817302024210 | BL240 | BL240 | Alanine Aminotransferase Reagent (ALT) | CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240 | CAROLINA LIQUID CHEMISTRIES CORPORATION |