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 | 07613336121177 | 08057532190 | 08057532190 | Creatinine Jaffe Gen.2 | ROCHE DIAGNOSTICS GMBH | |
2 | 05060500091873 | VI560-1200 | VI560-1200 | Creatinine Reagent 4 X 67 mL + 4 X 67 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
3 | 05060500090784 | VI562-L | VI562-L | Creatinine Picrate Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
4 | 05060500090777 | VI561-L | VI561-L | Creatinine Decolorizing Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
5 | 05060500090760 | VI560-911 | VI560-911 | Creatinine Reagent 4 X 50 mL + 4 X 50 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
6 | 05060500090753 | VI560-WK | VI560-WK | Creatinine Reagent 3 X 25 mL + 3 X 25 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
7 | 05060500090746 | VI5600-X | VI5600-X | Creatinine Reagent 1 X 250 mL + 1 X 250 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
8 | 05060500090739 | VI560-R | VI560-R | Creatinine Reagent 3 X 250 mL + 3 X 250 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
9 | 05055273208634 | CR8316 | CR8316 | The is intended for the quantitative in vitro diagnostic determination of Creati The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine | CREA | RANDOX LABORATORIES LIMITED |
10 | 05055273201932 | CR7948 | CR7948 | The is intended for the quantitative in vitro diagnostic determination of Creati The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine | CREA | RANDOX LABORATORIES LIMITED |
11 | 05055273201918 | CR524 | CR524 | The device intended for the quantitative in vitro determination of Creatinine in The device intended for the quantitative in vitro determination of Creatinine in serum, plasma or urine | CREA | RANDOX LABORATORIES LIMITED |
12 | 05055273201901 | CR510 | CR510 | CREATININE (CREA) | RANDOX LABORATORIES LIMITED | |
13 | 05055273201895 | CR3814 | CR3814 | The is intended for the quantitative in vitro diagnostic determination of Creati The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine | CREA | RANDOX LABORATORIES LIMITED |
14 | 05055273201888 | CR2804 | CR2804 | The CREA method used on the Dimension clinical chemistry system is an in vitro d The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic device intended for the quantitative determination of Creatinine in serum, plasma or urine | CREA | RANDOX LABORATORIES LIMITED |
15 | 04015630930777 | 6407137190 | 6407137190 | Creatinine Jaff Gen2 | ROCHE DIAGNOSTICS GMBH | |
16 | 04015630926824 | 5401755190 | 5401755190 | Creatinine Jaff Gen2 compensated) | ROCHE DIAGNOSTICS GMBH | |
17 | 04015630922284 | 4810716190 | 4810716190 | Creatinine Jaff Gen2 | ROCHE DIAGNOSTICS GMBH | |
18 | 04015630918355 | 11929941216 | 11929941216 | Creatinine Jaff method | ROCHE DIAGNOSTICS GMBH | |
19 | 04015630910762 | 11875663216 | 11875663216 | Creatinine Jaff method | ROCHE DIAGNOSTICS GMBH | |
20 | 04015630910427 | 11875418216 | 11875418216 | Creatinine Jaff method | ROCHE DIAGNOSTICS GMBH | |
21 | 03610230006955 | 1300023842 | Yumizen C1200 Creatinine Jaffé | HORIBA ABX SAS | ||
22 | 03610230005736 | 1220001933 | ABX PENTRA CREATININE 120 CP | HORIBA ABX SAS | ||
23 | 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. |
24 | 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. |
25 | 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. |
26 | 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. |
27 | EABA40000331 | 400-0033 | 400-0033 | The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine 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 Kidney Check | ABAXIS, INC. |
28 | 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. |
29 | 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. |
30 | 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. |
31 | 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. |
32 | EABA40000241 | 400-0024 | 400-0024 | The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyz The Piccolo® Basic Metabolic 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 calcium, chloride, creatinine, glucose, 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 Basic Metabolic Panel | ABAXIS, INC. |
33 | EABA40000231 | 400-0023 | 400-0023 | The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or The Piccolo® MetLyte 8 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 chloride, creatine kinase, creatinine, glucose, 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 MetLyte 8 Panel | ABAXIS, INC. |
34 | 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. |
35 | 00857969006112 | SA1012 | SA1012 | Creatinine Reagent | ACE | ALFA WASSERMANN, INC. |
36 | 00857969006068 | RX1012 | RX1012 | Creatinine Reagent | ACE | ALFA WASSERMANN, INC. |
37 | 00852169008126 | CRE1120 | CRE1120 | In Vitro Diagnostics testing kit R1:3X50mL, R2:3X10mL | ClearChem Diagnostics Inc. Creatinine (Jaffe) | CLEARCHEM DIAGNOSTICS INC. |
38 | 00851445007181 | GEN-CREA R2(Acid) | GEN-CREA R2(Acid) | 10/17/2022 | GENCHEM™ Creatinine Test Reagent | GENCHEM INC |
39 | 00851445007174 | GEN-CREA R1(Base) | GEN-CREA R1(Base) | 10/17/2022 | GENCHEM™ Creatinine Test Reagent | GENCHEM INC |
40 | 00845275003031 | TR35121 | Thermo Scientific Infinity™ | FISHER DIAGNOSTICS | ||
41 | 00817302024326 | CC448 | CC448 | CREATININE CHECK | CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE CHECK REAGENT KIT CC448 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
42 | 00817302020564 | 88809 | 88809 | CREA3 (Creatinine) - Modular & CX3 Reagent 3 x 2000 mL | CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE REAGENT KIT 88809 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
43 | 00817302020557 | CC243 | CC243 | CREA (Creatinine) 2 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CREA CREATININE REAGENT CC243 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
44 | 00817302020540 | AU-243 | AU-243 | CREA (Creatinine) 3 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CREA RGT. KIT AU-243 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
45 | 00817274022337 | OCRE2-50 | OCRE2-50 | CREATININE (5 x 50mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
46 | 00817274021460 | CRES-3U | CREATININE STANDARD (1x 3mL) Unlabeled Vial | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
47 | 00817274021453 | CRES-3 | CREATININE STANDARD (1x 3mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
48 | 00817274021446 | CRE2-BUL | CREATININE SINGLE VIAL BULK (in 20L Pkg) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
49 | 00817274021439 | DG-CRE2-125 | CREATININE LIQUID (2x 125mL + 1x 3mL Standard) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
50 | 00817274021422 | DG-CRE2-1L | CREATININE LIQUID (1 x 1 Liter + 1 x 5mL Standard) | JAS Diagnostics | DREW SCIENTIFIC, INC. |