No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00817302024562 | ST213 | ST213 | Triglycerides (TRIG) Reagent | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDES REAGENT KIT ST213 |
2 | 00817302024524 | ST160 | ST160 | WASH CONCENTRATE | JCB | DETERGENT | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® WASH CONCENTRATE ST160 |
3 | 00817302024500 | DT909 | DT909 | ISE CALIBRATOR 2 | JIX | Calibrator, multi-analyte mixture | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909 |
4 | 00817302024463 | DT618 | DT618 | Iron (Total) Reagent w/ Standard | JIY | Photometric method, iron (non-heme) | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT DT618 |
5 | 00817302024401 | DT211 | DT211 | Cholesterol (CHOL) Reagent | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT DT211 |
6 | 00817302023169 | CLC480i | CLC480i | CLC480 Chemistry Analyzer W/ISE | CFR,JJE | HEXOKINASE, GLUCOSE,ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | CLC480 Chemistry Analyzer W/ISE |
7 | 00817302023138 | CC229 | CC229 | DBIL (Direct Bilirubin) 2 x 200 tests | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® DBIL DIRECT BILIRUBIN REAGENT CC230 |
8 | 00817302023053 | DT229 | DT229 | DBIL (Direct Bilirubin) 4 x 300 tests | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® DBIL REAGENT PRODUCT NO. DT229 |
9 | 00817302023015 | DT206 | DT206 | ALP (Alkaline Phosphatase) 4 x 275 tests | CJE | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® ALP REAGENT PRODUCT NO. DT206 |
10 | 00817302022292 | DT428 | DT428 | Fentanyl Enzyme Immunoassay | DJG | Enzyme immunoassay, opiates | 2 | Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428 |
11 | 00817302022186 | ST616 | ST616 | HDLD (HDL Cholesterol Direct) w/ cal 2 x 250 tests | LBR,LBS | LDL & VLDL PRECIPITATION, HDL,LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE LDL & VLDL PRECIPITATION, HDL,LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HDL RGT KIT Product No. ST616 |
12 | 00817302022179 | 7-H7541-CAL | 7-H7541-CAL | HbA1c (Hemoglobin A1c) calibrator | LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CAL SET PART# 7-H7541-CAL |
13 | 00817302022148 | ST300 | ST300 | HbA1c 2 x 150 tests | LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HbA1c RGT KIT Pt No. ST300 |
14 | 00817302022018 | DT423 | DT423 | XTSY (Ecstasy) 2 x 500 tests | DKZ | ENZYME IMMUNOASSAY, AMPHETAMINE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® XTSY RGT KIT Product No. DT423 |
15 | 00817302021929 | DT419 | DT419 | OXYC (Oxycodone) 2 x 500 tests | DJG,DLJ,LAS | ENZYME IMMUNOASSAY, OPIATES,CALIBRATORS, DRUG SPECIFIC,DRUG SPECIFIC CONTROL MATERIALS | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® OXYC REAGENT KIT Product No. DT419 |
16 | 00817302021868 | DT415 | DT415 | METD (Methadone) 2 x 500 tests | DJR | ENZYME IMMUNOASSAY, METHADONE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT KIT Product No. DT415 |
17 | 00817302021820 | DT417 | DT417 | BARB (Barbiturates) 2 x 500 tests | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT KIT Product No. DT417 |
18 | 00817302021813 | DT412 | DT412 | AMPH (Amphetamines) 2 x 500 tests | DKZ | ENZYME IMMUNOASSAY, AMPHETAMINE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT KIT Product No. DT412 |
19 | 00817302021745 | AU-410A | AU-410A | THC (Cannabinoid) 50 ng/mL 2 x 625 tests | DLJ,LAS,LDJ | CALIBRATORS, DRUG SPECIFIC,DRUG SPECIFIC CONTROL MATERIALS,ENZYME IMMUNOASSAY, C CALIBRATORS, DRUG SPECIFIC,DRUG SPECIFIC CONTROL MATERIALS,ENZYME IMMUNOASSAY, CANNABINOIDS | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® THC50 RGT. KIT AU-410A |
20 | 00817302021585 | CC411A | CC411A | OP (Opiates) CX/LX/DXC 1 x 250 tests | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | CAROLINA LIQUID CHEMISTRIES CORP.™ OP OPIATES CC411A |
21 | 00817302021417 | MR415 | MR415 | METD (Methadone) 2 x 100 tests | DJR | ENZYME IMMUNOASSAY, METHADONE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT MR415 |
22 | 00817302021400 | CC442 | CC442 | Hydrocodone | DJG,LAS,DLJ | ENZYME IMMUNOASSAY, OPIATES,DRUG SPECIFIC CONTROL MATERIALS,CALIBRATORS, DRUG SPECIFIC | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® HYDRO 100 REAGENT KIT CC442 |
23 | 00817302021332 | MR421 | MR421 | ETHA (Alcohol) w/ cal 2 x 100 tests | DIC,DKC,DNN | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD,ALCOHOL CONTRO ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD,ALCOHOL CONTROL MATERIALS,CALIBRATORS, ETHYL ALCOHOL | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421 |
24 | 00817302021301 | AU-426 | AU-426 | EDDP (Methadone Metabolites) 2 x 625 tests | DLJ,DJR | CALIBRATORS, DRUG SPECIFIC,ENZYME IMMUNOASSAY, METHADONE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® EDDP RGT. KIT AU-426 |
25 | 00817302021110 | BL417 | BL417 | BARB (Barbiturates) 2 x 100 tests | DLJ,DIS,LAS | CALIBRATORS, DRUG SPECIFIC,ENZYME IMMUNOASSAY, BARBITURATE,DRUG SPECIFIC CONTROL MATERIALS | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT. KIT BL-417 |
26 | 00817302021028 | MR412 | MR412 | AMPH (Amphetamines) 2 x 100 tests | DKZ | ENZYME IMMUNOASSAY, AMPHETAMINE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT MR412 |
27 | 00817302021011 | MR425 | MR425 | 6AM (6-Acetylmorphine) 2 x 100 tests | LAS,DLJ,DJG | DRUG SPECIFIC CONTROL MATERIALS,CALIBRATORS, DRUG SPECIFIC,ENZYME IMMUNOASSAY, OPIATES | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT MR425 |
28 | 00817302020922 | CC634 | CC634 | C3 (Complement 3) 2 x 60 tests | CZW | COMPLEMENT C3, ANTIGEN, ANTISERUM, CONTROL | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® C3 Complement C3 CC634 |
29 | 00817302020793 | ST425 | ST425 | 6AM (6-Acetylmorphine) 3 x 375 tests | DJG,DKB,DIF | ENZYME IMMUNOASSAY, OPIATES,CALIBRATORS, DRUG MIXTURE,DRUG MIXTURE CONTROL MATERIALS | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST425 |
30 | 00817302020755 | CC217 | CC217 | TP (Total Protein) 2 X 300 TESTS | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | CAROLINA LIQUID CHEMISTRIES CORP.™ TP TOTAL PROTEIN REAGENT CC217 |
31 | 00817302020670 | 88811 | 88811 | ISE (Electrolytes) Reference - CX3 Reagent 1 x 2000 mL | CEM,CGZ,JFP,JGS,JFL | ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, CALCIUM,ELECTRODE, ION SPECIFIC, SODIUM,PH RATE MEASUREMENT, CARBON-DIOXIDE | 2 | ISE ELECTROLYTE REFERENCE 88811 |
32 | 00817302020656 | 88807 | 88807 | GLU3 (Glucose) - CX3 Reagent 1 x 500 mL | CFR | HEXOKINASE, GLUCOSE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® GLUCOSE REAGENT 88807 |
33 | 00817302020625 | BL208 | BL208 | GLU (Glucose) 3 x 110 tests | CFR | HEXOKINASE, GLUCOSE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® GLU RGT. KIT BL-208 |
34 | 00817302020571 | ST229 | ST229 | DBIL (Direct Bilirubin) 4 x 150 tests | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 DBIL RGT KIT Product No. ST229 |
35 | 00817302020465 | CC909 | CC909 | Cal Level 2 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6 x 25 mL | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 2 CC909 |
36 | 00817302020410 | BL251 | BL251 | CA (Calcium) 3 x 160 tests | CJY | AZO DYE, CALCIUM | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT BL-251 |
37 | 00817302020366 | BL252 | BL252 | BUN (Blood Urea Nitrogen) 3 x 170 tests | CDQ | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT BL-252 |
38 | 00817302020274 | ST227 | ST227 | AMY (Amylase) 4 x 250 tests | JFJ | CATALYTIC METHODS, AMYLASE | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AMY RGT KIT Product No. ST227 |
39 | 00817302020250 | BL206 | BL206 | ALP (Alkaline Phosphatase) 3 x 100 tests | CJE | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT BL-206 |
40 | 00817302020052 | BL343 | BL343 | CREAu (Creatinine, Urine) only | JFY,JJX | ENZYMATIC METHOD, CREATININE,Single (specified) analyte controls (assayed and unassayed) | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® UCREA RGT. KIT BL-343 |
41 | 00817302024630 | UDT-CNTL | UDT-CNTL | MULTI-DRUG CONTROL (UDT-CNTL) | DIF | Drug mixture control materials | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® MULTI-DRUG CONTROL UDT-CNTL |
42 | 00817302024555 | ST212 | ST212 | Uric Acid (URIC) Reagent | KNK | Acid, uric, uricase (colorimetric) | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT ST212 |
43 | 00817302024548 | ST211 | ST211 | Cholesterol (CHOL) Reagent | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT ST211 |
44 | 00817302024241 | CC209 | CC209 | Gamma Glutamyl Transferase (GGT) | CKB | Acid phosphatase, naphthyl phosphate | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT CC209 |
45 | 00817302024142 | AU-661 | AU-661 | LDL Cholesterol Reagent (LDL) w/ Calibrator | MRR | SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN | 1 | CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661 |
46 | 00817302022933 | ST326B | ST326B | Methadone Metabolite Enzyme Immunoassay | DJR | Enzyme immunoassay, methadone | 2 | Carolina Liquid Chemistries Methadone Metabolite EDDP |
47 | 00817302022926 | AU-426B | AU-426B | Methadone Metabolite Enzyme Immunoassay | DJR | Enzyme immunoassay, methadone | 2 | Carolina Liquid Chemistries Methadone Metabolite EDDP |
48 | 00817302022575 | ST426B | ST426B | Methadone Metabolite Enzyme Immunoassay | DJR | Enzyme immunoassay, methadone | 2 | Carolina Liquid Chemistries Methadone Metabolite EDDP |
49 | 00817302022568 | BL-426B | BL-426B | Methadone Metabolite Enzyme Immunoassay | DJR | Enzyme immunoassay, methadone | 2 | Carolina Liquid Chemistries Methadone Metabolite EDDP |
50 | 00817302022155 | BL300 | BL300 | HbA1c (Hemoglobin A1c Direct) 2 x 100 tests | LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | 2 | CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 15099590625672 | 476826 | 476826 | Alanine Aminotransferase Reagent (ALT 2 x 400) | Synchron | BECKMAN COULTER, INC. |
2 | 15099590575205 | 442620 | 442620 | Alanine Aminotransferase Reagent (ALT 2 x 200) | Synchron | BECKMAN COULTER, INC. |
3 | 15099590575090 | 467840 | 467840 | Alanine Aminotransferase Reagent (ALT- 2 x 300) | Synchron | BECKMAN COULTER, INC. |
4 | 15099590575083 | 467848 | 467848 | Alanine Aminotransferase Reagent (ALT- 2 x 100) | Synchron | BECKMAN COULTER, INC. |
5 | 15099590060022 | OSR6607 | ALT | AU | BECKMAN COULTER, INC. | |
6 | 15099590010065 | OSR6107 | ALT | AU | BECKMAN COULTER, INC. | |
7 | 10758750032136 | 6844288 | 6844288 | VITROS Chemistry Products ALTV Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
8 | 10758750031757 | 6844291 | 6844291 | VITROS XT Chemistry Products ALTV-AST Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
9 | 10758750009480 | 1655281 | 1655281 | VITROS Chemistry Products ALT Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
10 | 07613336120989 | 08056773190 | 08056773190 | Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation | ROCHE DIAGNOSTICS GMBH | |
11 | 05060500091712 | UV185-1200 | UV185-1200 | ALT Reagent 8 X 67 mL + 2 X 67 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
12 | 05060500090227 | UV182-L | UV182-L | ALT Starter Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
13 | 05060500090210 | UV184-L | UV184-L | ALT Substrate Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
14 | 05060500090203 | UV185-911 | UV185-911 | ALT Reagent 4 X 50 mL + 1 X 50 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
15 | 05060500090197 | UV185-WK | UV185-WK | ALT Reagent 4 X 25 mL + 4 X 6.25 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
16 | 05060500090180 | UV185-X | UV185-X | ALT Reagent 1 X 100 mL + 1 X 25 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
17 | 05060500090173 | UV185-R | UV185-R | ALT Reagent 4 X 100 mL + 1 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
18 | 05055273208160 | AL8304 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | ||
19 | 05055273208153 | AL8006 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | ||
20 | 05055273200249 | AL7930 | AL7930 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
21 | 05055273200232 | AL7904 | AL7904 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
22 | 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 |
23 | 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 |
24 | 05055273200195 | AL2360 | AL2360 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
25 | 05055273200188 | AL146 | AL146 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
26 | 05055273200171 | AL1268 | AL1268 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
27 | 05055273200164 | AL1205 | AL1205 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
28 | 05055273200157 | AL1200 | AL1200 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
29 | 05055273200133 | AL100 | AL100 | ALANINE AMINOTRANSFERASE (ALT) | RANDOX LABORATORIES LIMITED | |
30 | 04015630928927 | 5850797190 | 5850797190 | Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation | ROCHE DIAGNOSTICS GMBH | |
31 | 04015630927425 | 5531462190 | 5531462190 | Alanine Aminotransferase / Aspartate Aminotransferase acc. to IFCC with PYP | ROCHE DIAGNOSTICS GMBH | |
32 | 04015630921973 | 4718569190 | 4718569190 | Alanine aminotransferase acc. IFCC with or without PYP | ROCHE DIAGNOSTICS GMBH | |
33 | 04015630920532 | 4467388190 | 4467388190 | Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation | ROCHE DIAGNOSTICS GMBH | |
34 | 04015630913862 | 20764957322 | 20764957322 | Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation | ROCHE DIAGNOSTICS GMBH | |
35 | 03610230006856 | 1300023832 | Yumizen C1200 AST | HORIBA ABX SAS | ||
36 | 03610230006801 | 1300023797 | Yumizen C1200 ALT | HORIBA ABX SAS | ||
37 | 03610230004906 | 1220001627 | ABX PENTRA ALT CP | HORIBA ABX SAS | ||
38 | 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. |
39 | 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. |
40 | 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. |
41 | 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. |
42 | 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. |
43 | 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. |
44 | 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. |
45 | 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. |
46 | 00857969006662 | SA1052 | SA1052 | ALT Reagent | ACE | ALFA WASSERMANN, INC. |
47 | 00857969006556 | SA1046 | SA1046 | ALT Reagent | ACE | ALFA WASSERMANN, INC. |
48 | 00852169008034 | ALT1020 | ALT1020 | In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL | ClearChem Diagnostics Inc. Alanine aminotransferase (ALT) | CLEARCHEM DIAGNOSTICS INC. |
49 | 00842768034336 | 10475530 | DF143 | Alanine Aminotransferase Flex® reagent cartridge, 240 tests | Dimension® Flex® reagent cartridge ALTI | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00842768034312 | 10635565 | K2143 | Alanine Aminotransferase Flex® reagent cartridge, 480 tests | Dimension Vista® Flex® reagent cartridge ALTI | SIEMENS HEALTHCARE DIAGNOSTICS INC. |