No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00842768039010 | 10642445 | DF150 | Alkaline Phosphatase Flex® reagent cartridge, 360 tests | CJO | ALPHA-NAPHTHYL PHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES | Dimension® Flex® reagent cartridge ALPI | |
2 | 00842768037740 | 10706480 | RF634 | Dimension® EXL™ Total Vitamin D, 200 tests (4x50) | MRG | SYSTEM, TEST, VITAMIN D | Dimension® EXL™ Total Vitamin D | |
3 | 00842768037214 | 10636928 | 778041.931 | Dimension® EXL™ 200 System | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Dimension® EXL™ 200 Integrated Chemistry System |
4 | 00842768034138 | 10470441 | 9R529UL | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 | DKB,DIF | CALIBRATORS, DRUG MIXTURE,DRUG MIXTURE CONTROL MATERIALS | 1 | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 |
5 | 00842768033322 | 10636333 | KC470 | DGTX Calibrator, 2x5x5.0mL | JIT | CALIBRATOR, SECONDARY | 2 | Dimension Vista® DGTX CAL |
6 | 00842768030413 | 10484429 | K800A | V-LYTE Integrated Multisensor | CEM,JGS,CGZ | ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, IO ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION-SPECIFIC, CHLORIDE | 2 | Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl- |
7 | 00842768030024 | 10472176 | 778021.931 | Dimension® EXL with LM system | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Dimension® EXL™ with LM Integrated Chemistry System |
8 | 00842768029912 | 10464526 | RF623 | LOCI N-terminal Pro-Brain Natriuretic Peptide Flex® reagent cartridge, 120 tests | NBC | TEST,NATRIURETIC PEPTIDE | Dimension® EXL™ LOCI® Module Flex® reagent cartridge NTP | |
9 | 00842768029332 | 10488446 | KC605 | LOCI 7 Calibrator, 2x5x2mL | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Dimension Vista® LOCI 7 CAL |
10 | 00842768028915 | 10472099 | KS860 | Small Sample Container (SSC), 1000 Pieces | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | Dimension Vista® Small Sample Container (SSC) | |
11 | 00842768027307 | 11306492 | 11306492 | ADVIA 120/2120/2120i Vent Line Wash Kit | JCB | DETERGENT | 1 | ADVIA 120/2120/2120i Vent Line Wash Kit |
12 | 00842768025556 | 10464510 | DF32 | Creatine Kinase MB Flex® reagent cartridge, 120 tests | CGS | NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES | Dimension® Flex® reagent cartridge MBI | |
13 | 00842768025112 | 10464321 | K6423A | NT-proBNP Flex® reagent cartridge, 80 Tests | NBC | TEST,NATRIURETIC PEPTIDE | Dimension Vista® Flex® reagent cartridge PBNP | |
14 | 00842768023453 | 10445476 | 9Q229 | Emit® II Plus Methaqualone Assay labeled with the Beckman Coulter® name | KXS | RADIOIMMUNOASSAY, METHAQUALONE | 2 | Emit® II Plus Methaqualone Assay |
15 | 00842768023354 | 10445415 | 9B229 | Emit® II Plus Opiate Assay labeled with the Beckman Coulter® name | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Emit® II Plus Opiate Assay |
16 | 00842768022111 | 10464331 | DF306 | Sirolimus Flex® reagent cartridge, 80 tests | NRP | Sirolimus test system | Dimension® Flex® reagent cartridge SIRO | |
17 | 00842768022050 | 10459408 | DF22 | Ethyl Alcohol Flex® reagent cartridge, 120 tests | DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | Dimension® Flex® reagent cartridge ETOH | |
18 | 00842768016653 | 10445138 | K6444 | Folate Flex® reagent cartridge, 120 tests | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | Dimension Vista® Flex® reagent cartridge FOL | |
19 | 00842768016455 | 10445187 | KC510 | Drugs of Abuse Calibrator, 4x2.5mL / 2x2.6mL | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Dimension Vista® UDAT CAL |
20 | 00842768016028 | 10444897 | RF434 | CardioPhase® high sensitivity CRP Flex® reagent cartridge, 120 tests | NQD | CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | Dimension CardioPhase high sensitivity CRP Flex reagent cartridge | |
21 | 00842768015731 | 10445104 | K6412 | Thyroid Stimulating Hormone Flex® reagent cartridge, 960 Tests | JLW | RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE | Dimension Vista® Flex® reagent cartridge TSH | |
22 | 00842768015618 | 10445160 | K1023 | Calcium Flex® reagent cartridge, 1320 tests | CIC | CRESOLPHTHALEIN COMPLEXONE, CALCIUM | Dimension Vista® Flex® reagent cartridge CA | |
23 | 00842768015496 | 10445102 | K6075 | Thyronine Uptake Flex® reagent cartridge, 160 tests | KHQ | RADIOASSAY, TRIIODOTHYRONINE UPTAKE | Dimension Vista® Flex® reagent cartridge TU | |
24 | 00842768015328 | 10445097 | K6420 | Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 100 tests | JHY | COLORIMETRIC METHOD, CPK OR ISOENZYMES | Dimension Vista® Flex® reagent cartridge MMB | |
25 | 00842768015281 | 10445132 | K4113 | Lidocaine Flex® reagent cartridge, 60 tests | KLR | ENZYME IMMUNOASSAY, LIDOCAINE | Dimension Vista® Flex® reagent cartridge LIDO | |
26 | 00842768015199 | 10445106 | K6416 | Free Triiodothyronine Flex® reagent cartridge, 120 tests | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | Dimension Vista® Flex® reagent cartridge FT3 | |
27 | 00842768015090 | 10445143 | K1027 | Cholesterol Flex® reagent cartridge, 600 tests | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | Dimension Vista® Flex® reagent cartridge CHOL | |
28 | 00842768014352 | 10445423 | 9D039UL | Syva® Emit® II Plus Barbiturate Assay - 28 mL Kit | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | Syva® Emit® II Plus Barbiturate Assay |
29 | 00842768014345 | 10445418 | 9C039UL | Syva® Emit® II Plus Amphetamines Assay - 29 mL kit | DKZ | ENZYME IMMUNOASSAY, AMPHETAMINE | 2 | Syva® Emit® II Plus Amphetamines Assay |
30 | 00842768014338 | 10445414 | 9B039UL | Syva® Emit® II Plus Opiate Assay - 29 mL Kit | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Syva® Emit® II Plus Opiate Assay |
31 | 00842768014086 | 10445042 | D828 | Cuvette Cartridge - Dimension® - 1 Cartridge | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Dimension® Cuvette Cartridge |
32 | 00842768014024 | 10444872 | S640 | Quiklyte Diluent Check, 60mL | CGZ,JGS,JFL,CEM | ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, SODIUM,PH RATE MEASUR ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, SODIUM,PH RATE MEASUREMENT, CARBON-DIOXIDE,ELECTRODE, ION SPECIFIC, POTASSIUM | 2 | Dimension® QuikLYTE® Integrated Multisensor Diluent Check |
33 | 00842768013911 | 10444914 | RF530 | Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests | DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | Dimension Human Chorionic Gonadotropin Flex reagent cartridge | |
34 | 00842768013843 | 10444907 | RF422A | Myoglobin Flex® reagent cartridge, 120 tests | DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge MYO | |
35 | 00842768013775 | 10445035 | RD703 | Sample Probe Cleaner, 1x1 Liter | JJE,JMG | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,Radioimmunoassay ( ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,Radioimmunoassay (two-site solid phase), ferritin | 1 | Dimension® Sample Probe Cleaner |
36 | 00842768013720 | 10445024 | RC422 | Myoglobin Calibrator, 2x5x1mL | JIT | CALIBRATOR, SECONDARY | Dimension® MYO Calibrator | |
37 | 00842768005848 | 10444924 | DF94A | Urine Phencyclidine Screen Flex® reagent cartridge, 80 tests | LCM | Enzyme immunoassay, phencyclidine | Dimension® Flex® reagent cartridge PCP | |
38 | 00842768005527 | 10444894 | DF37 | C-Reactive Protein Flex® reagent cartridge, 120 tests | DCK | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | Dimension® Flex® reagent cartridge CRP | |
39 | 00842768005367 | 10444939 | DF132 | Lithium Flex® reagent cartridge, 80 tests | JIH | FLAME PHOTOMETRY, LITHIUM | Dimension® Flex® reagent cartridge LI | |
40 | 00842768005275 | 10444948 | DF11 | Acid Phosphatase Flex® reagent cartridge, 120 tests | CKE | Acid phosphatase, thymolphthale inmonophosphate | Dimension® Flex® reagent cartridge ACP | |
41 | 00842768005268 | 10444934 | DF108 | Cyclosporine Extended Range Flex® reagent cartridge, 80 tests | MKW | CYCLOSPORINE | Dimension® Flex® reagent cartridge CSAE | |
42 | 00842768005183 | 10445025 | DC50 | Prealbumin Calibrator, 2x5x1mL | JIT | CALIBRATOR, SECONDARY | Dimension® PALB Calibrator | |
43 | 00842768005091 | 10444993 | DC31 | Total Protein/Albumin Calibrator, 2x3x2mL | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | Dimension® TP/ALB Calibrator | |
44 | 00842768005084 | 10444988 | DC30 | C-Reactive Protein Calibrator, 2x5x1mL | DCK | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | Dimension® CRP Calibrator | |
45 | 00842768004445 | 10445064 | CCANS | Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube in the sample manager. | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | Stratus® CS STAT Fluorometric Analyzer Cannula | |
46 | 00842768004438 | 10445063 | CCANBD | For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tube For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer. | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | Stratus® CS STAT Fluorometric Analyzer Cannula | |
47 | 00630414600284 | 10995715 | 10995715 | Vitamin B12 (VB12) Atellica IM - RGT 500T | CDD | RADIOASSAY, VITAMIN B12 | Atellica IM VB12 | |
48 | 00842768001888 | 10445424 | 9D129UL | Syva® Emit® II Plus Barbiturate Assay - 1 L Kit | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | Syva® Emit® II Plus Barbiturate Assay |
49 | 00842768001871 | 10445422 | 9D029UL | Syva® Emit® II Plus Barbiturate Assay - 115 mL Kit | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | Syva® Emit® II Plus Barbiturate Assay |
50 | 00842768001864 | 10445421 | 9C329UL | Syva® Emit® II Plus Amphetamines Assay - 1L Kit | DKZ | ENZYME IMMUNOASSAY, AMPHETAMINE | 2 | Syva® Emit® II Plus Amphetamines Assay |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 15099590625610 | 442740 | 442740 | Total Protein Reagent (TP 2 x 300) | Synchron | BECKMAN COULTER, INC. |
2 | 15099590575151 | 445860 | 445860 | Microprotein Reagent (M-TP 2 x 50) | Synchron | BECKMAN COULTER, INC. |
3 | 15099590233327 | 465986 | 465986 | Total Protein Reagent | Synchron | BECKMAN COULTER, INC. |
4 | 15099590060091 | OSR6632 | Total Protein | AU | BECKMAN COULTER, INC. | |
5 | 15099590020347 | OSR6270 | Urinary/CSF Protein | AU | BECKMAN COULTER, INC. | |
6 | 15099590020156 | OSR6232 | Total Protein | AU | BECKMAN COULTER, INC. | |
7 | 15099590010676 | OSR6170 | Urinary/CSF Protein | AU | BECKMAN COULTER, INC. | |
8 | 15099590010294 | OSR6132 | Total Protein | AU | BECKMAN COULTER, INC. | |
9 | 10758750004850 | 8392292 | 8392292 | VITROS Chemistry Products TP Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
10 | 10758750004539 | 8208431 | 8208431 | VITROS Chemistry Products PROT Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
11 | M0515210120 | 5210-12 | 5210-12 | QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyro QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems. | QuanTtest Red Pyrogallol Red Reagent | QUANTIMETRIX CORPORATION |
12 | M0513410021 | 3410-02 | 3410-02 | QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl. | QuanTtest Human Protein Standards Set | QUANTIMETRIX CORPORATION |
13 | M0512210021 | 2210-02 | 2210-02 | The quanTtest red Total Protein Assay System is intended for the quantitative de The quanTtest red Total Protein Assay System is intended for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems. The quanTtest red Total Protein Assay System provides a simple method of protein quantitation using microliter samples of urine or cerebrospinal fluid. Total Protein is measured by the dye binding method using a complex of pyrogallol red and molybdenum acid (Mo+6). At low pH the dye is red and changes to blue when complexed with protein.The kit consists of reagent, controls for both CSF and urine chemistry, and four reagent standards: Level 2 (25 mg/dL), Level 3 (50 mg/dL), Level 4 (100 mg/dL), and Level 5 (200 mg/dL). | QuanTtest Red Reagent Total Protein Assay System | QUANTIMETRIX CORPORATION |
14 | 07613336121528 | 08058652190 | 08058652190 | Total Protein Gen.2 | ROCHE DIAGNOSTICS GMBH | |
15 | 06970291985208 | None | Total Protein Kit (Biuret Method) (2-Part Reagents) | MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. | ||
16 | 06970291985192 | None | Total Protein Kit (Biuret Method) | MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. | ||
17 | 05060500091941 | VI530-1200 | VI530-1200 | Total Protein Reagent 6 X 67 mL + 3 X 67 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
18 | 05060500091361 | VI133-L | VI133-L | Total Protein Biuret Reagent 6 X 1000 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
19 | 05060500091354 | VI131-L | VI131-L | Total Protein Buffer Reagent 6 X 1000 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
20 | 05060500091347 | VI530-911 | VI530-911 | Total Protein Reagent 4 X 50 mL + 2 X 40 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
21 | 05060500091330 | VI530-WK | VI530-WK | Total Protein Reagent 3 X 25 mL + 3 X 12.5 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
22 | 05060500091323 | VI530-X | VI530-X | Total Protein Reagent 1 X 250 mL + 1 X 125 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
23 | 05060500091316 | VI530-R | VI530-R | Total Protein Reagent 4 X 250 mL + 2 X 250 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
24 | 05060500091309 | VI135-L | VI135-L | Total Protein Single Reagent 6 X 1000 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
25 | 05060500091293 | VI135-X | VI135-X | Total Protein Single Reagent 2 X 250 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
26 | 05060500091286 | VI135-R | VI135-R | Total Protein Single Reagent 6 X 250 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
27 | 05055273209518 | TP8336 | TOTAL PROTEIN 2 (TP 2) | RANDOX LABORATORIES LIMITED | ||
28 | 05055273209501 | TP8066 | TOTAL PROTEIN 2 (TP 2) | RANDOX LABORATORIES LIMITED | ||
29 | 05055273206562 | TP4001 | For the quantitative in vitro determination of Total Protein in serum. | TOTAL PROTEIN 2 (TP 2) | RANDOX LABORATORIES LIMITED | |
30 | 05055273206555 | TP3869 | For the quantitative in vitro determination of Total Protein in serum and plasma. | TOTAL PROTEIN (TP) | RANDOX LABORATORIES LIMITED | |
31 | 05055273206531 | TP245 | For the quantitative in vitro determination of Total Protein in serum and plasma. | TOTAL PROTEIN (TP) | RANDOX LABORATORIES LIMITED | |
32 | 04015630925100 | 5171385190 | 5171385190 | Total Protein Gen2 | ROCHE DIAGNOSTICS GMBH | |
33 | 04015630922833 | 4657586190 | 4657586190 | Total Protein Gen2 monocromatic | ROCHE DIAGNOSTICS GMBH | |
34 | 04015630918928 | 3183734190 | 3183734190 | Total Protein Gen2 | ROCHE DIAGNOSTICS GMBH | |
35 | 04015630912445 | 12000920216 | 12000920216 | Total Protein | ROCHE DIAGNOSTICS GMBH | |
36 | 04015630912438 | 12000903216 | 12000903216 | Total Protein | ROCHE DIAGNOSTICS GMBH | |
37 | 04015630911875 | 11929917216 | 11929917216 | Total Protein | ROCHE DIAGNOSTICS GMBH | |
38 | 03610230007174 | 1300023865 | Yumizen C1200 Total Protein | HORIBA ABX SAS | ||
39 | 03610230005729 | 1220001932 | ABX PENTRA TOTAL PROTEIN 100 CP | HORIBA ABX SAS | ||
40 | 03610230005224 | 1220001669 | ABX PENTRA TOTAL PROTEIN CP | HORIBA ABX SAS | ||
41 | 00896863002356 | 3410-02 | 3410-02 | QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl. | QuanTtest Human Protein Standards Set | QUANTIMETRIX CORPORATION |
42 | 00896863002349 | 5210-12 | 5210-12 | QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyro QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems. | QuanTtest Red Pyrogallol Red Reagent | QUANTIMETRIX CORPORATION |
43 | 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. |
44 | 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. |
45 | 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. |
46 | 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. |
47 | 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. |
48 | 00857969006235 | SA1022 | SA1022 | Total Protein Reagent | ACE | ALFA WASSERMANN, INC. |
49 | 00852169008249 | TPR1310 | TPR1310 | In Vitro Diagnostics testing kit R1:4X60mL | ClearChem Diagnostics Inc. Protein, Total | CLEARCHEM DIAGNOSTICS INC. |
50 | 00851445007303 | GEN-TP3 | GEN-TP3 | 10/17/2022 | GENCHEM™ Total Protein Reagent | GENCHEM INC |