| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08058056681768 | 1665001 | 1665001 | ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the p ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the preparation of the calibration for the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. | JIT | Calibrator, Secondary | 2 | ACE Calibrator |
| 2 | 08058056681980 | C22856 | C22856 | The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the dete The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only. | CJW | Bromcresol Purple Dye-Binding, Albumin | 2 | Albumin BCP (6x50 mL) |
| 3 | 08058056682314 | 04Y85-11 | 04Y85-11 | Lipase NG OC CTRL 2 must be used only to verify the performance of the Lipase NG Lipase NG OC CTRL 2 must be used only to verify the performance of the Lipase NG.Use the Control Material like the specimens, according to the indicated analytical procedure. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Lipase NG OC CTRL 2 |
| 4 | 08058056681782 | B82715 | B82715 | The Lipase NG assay is an in vitro diagnostic test used for the determination on The Lipase NG assay is an in vitro diagnostic test used for the determination on AU480 and AU680 automatic analyzers of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. | CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 | Lipase NG |
| 5 | 08058056681300 | A26854 | A26854 | Plasmaproteins Cal 3x must be used only for the calibration of the plasmaprotein Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests listed in the Assigned Concentrations Table (TcA) using immunoturbidimetric methods. Use the calibrator according to the indicated analytical procedure. For in vitro diagnostic use only. | JIX | Calibrator, Multi-Analyte Mixture | 2 | Plasmaproteins Cal 3x |
| 6 | 08058056680648 | A26838 | A26838 | The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprot The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprotein (AGP) in serum and plasma by immunoturbidimetry. For In Vitro Diagnostic Use only. | LKL | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | 1 | alpha 1-Acid Glycoprotein |
| 7 | 08058056680532 | 11206D | 11206D | Plasmaproteins Cal 3x must be used only for the calibration of the plasmaprotein Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests with immunoturbidimetric method.Use the Calibrator according to the indicated analytical procedure.For professional use only. For in vitro diagnostics use | JIX | Calibrator, Multi-Analyte Mixture | 2 | Plasmaproteins Cal 3x |
| 8 | 08058056680204 | 11211A | 11211A | Immuno Control Set is for use in quality control by monitoring accuracy and prec Immuno Control Set is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table.Use the Control Material like the specimens, according to the indicated analytical procedure.For professional use only. For In Vitro diagnostic use. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Immuno Control Set |
| 9 | 08058056682321 | 04Y85-20 | 04Y85-20 | The Lipase NG OC assay is an in vitro diagnostic test used for the determination The Lipase NG OC assay is an in vitro diagnostic test used for the determination of the Lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. For In Vitro Diagnostic use. | CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 | Lipase NG OC Reagent Kit |
| 10 | 08058056681751 | 1767001 | 1767001 | ACE Liquid reagent is for use in the determination of Angiotensin converting enz ACE Liquid reagent is for use in the determination of Angiotensin converting enzyme (ACE) activity in human serum or plasma.For In Vitro Diagnostic use. | KQN | Radioassay, Angiotensin Converting Enzyme | 2 | ACE Liquid |
| 11 | 08058056680105 | 16250 | 16250 | Clin Chem Control 2 is for use in quality control by monitoring accuracy and pre Clin Chem Control 2 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For In Vitro Diagnostic use. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Clin Chem Control 2 |
| 12 | 08058056681799 | B83544 | B83544 | Lipase NG Cal must be used only for the calibration of Lipase NG kinetic colorim Lipase NG Cal must be used only for the calibration of Lipase NG kinetic colorimetric direct determination.For In Vitro Diagnostic use only. | JIX | Calibrator, Multi-Analyte Mixture | 2 | Lipase NG Cal |
| 13 | 08058056681775 | 1667001 | 1667001 | ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monit ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ACE Control Set |
| 14 | 08058056680617 | 17401B | 17401B | The Lipase Color Liquid is an In Vitro Diagnostic test used for the determinatio The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. | CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 | Lipase Color Liquid |
| 15 | 08058056682307 | 04Y85-10 | 04Y85-10 | Lipase NG OC CTRL 1 must be used only to verify the performance of the Lipase NG Lipase NG OC CTRL 1 must be used only to verify the performance of the Lipase NG.Use the Control Material like the specimens, according to the indicated analytical procedure. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Lipase NG OC CTRL 1 |
| 16 | 08058056680709 | 17019H | 17019H | The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determinat The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determination of the cholinesterase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. | DLI | Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase | 1 | Cholinesterase Liquid |
| 17 | 08058056681263 | A26849 | A26849 | The Lambda light chains assay is an in vitro diagnostic test used for the quanti The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 and Unicel DxC 600 Systems. | DEH | Lambda, Antigen, Antiserum, Control | 2 | Lambda light chains |
| 18 | 08058056680136 | 16550 | 16550 | Clin Chem Cal must be used only for the calibration of clinical chemistry tests. Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only. | JIX | Calibrator, Multi-Analyte Mixture | 2 | Clin Chem Cal |
| 19 | 08058056680099 | 16150 | 16150 | Clin Chem Control 1 is for use in quality control by monitoring accuracy and pre Clin Chem Control 1 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For In Vitro Diagnostic use. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Clin Chem Control 1 |
| 20 | 08058056682291 | 04Y85-01 | 04Y85-01 | Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitr Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use. | JIT | Calibrator, Secondary | 2 | Lipase NG OC Cal |
| 21 | 08058056681911 | 115646 | 115646 | Latex immunoassay for the determination of the C-Reactive Protein (CRP) concentr Latex immunoassay for the determination of the C-Reactive Protein (CRP) concentration in serum and plasma on VITROS® 4600 Chemistry System and VITROS® 5600 Integrated System. The assay is intended for professional use only. For In Vitro diagnostic use only. | DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | CRP Ultra (MP) |
| 22 | 08058056681232 | A26842 | A26842 | The kit is intended for the quantitative determination of ceruloplasmin (CER) in The kit is intended for the quantitative determination of ceruloplasmin (CER) in serum and plasma by immunoturbidimetry. For in vitro diagnostic use only. | JFR | Indirect Copper Assay, Ceruloplasmin | 2 | Ceruloplasmin |
| 23 | 08058056681157 | A26845 | A26845 | The Kappa light chains assay is an in vitro diagnostic test used for the quantit The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 and Unicel DxC 600 Systems. | DFH | Kappa, Antigen, Antiserum, Control | 2 | Kappa light chains |
| 24 | 08058056680730 | 11065N | 11065N | The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric d The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric determination of ceruloplasmin in serum and plasma. The assay is intended for professional use only. For In Vitro diagnostic use. | JFR | Indirect Copper Assay, Ceruloplasmin | 2 | Ceruloplasmin |
| 25 | 08058056680587 | A53704 | A53704 | The Pancreatic Amylase assay is an in vitro diagnostic test used for the determi The Pancreatic Amylase assay is an in vitro diagnostic test used for the determination on AU480, AU680 and AU5800 automatic analyzers of the pancreatic amylase in serum and plasma by enzymatic colorimetric method. The assay is intended for professional use only. | JFJ | Catalytic Methods, Amylase | 2 | Pancreatic Amylase |
| 26 | 08058056680297 | A53720 | A53720 | The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitat The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC600, DxC800 and Synchron LX20 systems of the CK-MB isoenzyme activity of creatine kinase in serum and Li-heparin plasma by inhibition method. | JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 | CKMB UDR |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 05055273200034 | AB3800 | AB3800 | An Albumin test system is a device intended for the quantitative in vitro determ An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma. | ALB | RANDOX LABORATORIES LIMITED |
| 2 | 04015630990634 | 11815148216 | 11815148216 | AlbuminBCP AlbuminBCP | ROCHE DIAGNOSTICS GMBH | |
| 3 | 04015630928064 | 5975573190 | 5975573190 | Albumin BCP | ROCHE DIAGNOSTICS GMBH | |
| 4 | 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. |
| 5 | 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. |
| 6 | 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. |
| 7 | 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. |
| 8 | 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. |
| 9 | 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. |
| 10 | 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. |
| 11 | 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. |
| 12 | 00851445007006 | GEN-ALB | GEN-ALB | 10/17/2022 | GENCHEM™ Albumin Reagent | GENCHEM INC |
| 13 | 00842768015021 | 10445165 | K1013 | Albumin Flex® reagent cartridge, 1200 tests | Dimension Vista® Flex® reagent cartridge ALB | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 14 | 00842768005343 | 10444975 | DF13 | Albumin Flex® reagent cartridge, 480 tests | Dimension® Flex® reagent cartridge ALB | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 15 | 00817302020946 | AU-214 | AU-214 | ALB (Albumin) BCP 3 x 275 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 16 | 00817302020229 | CC214 | CC214 | ALB (Albumin) BCP 2 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 17 | 00630414947419 | 10711841 | 10711841 | Albumin - ADVIA Chem. - RGT - 4x1525 | ADVIA® Chemistry Albumin BCP Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 18 | 00630414947402 | 10711840 | 10711840 | Albumin - ADVIA Chem. - RGT - 4x800 | ADVIA® Chemistry Albumin BCP Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 19 | 00630414595825 | 11097530 | 11097530 | Albumin BCP (AlbP) Atellica CH - RGT 6400T | Atellica CH AlbP | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 20 | 00380740121723 | 08P0320 | 08P0320 | Alinity c Albumin BCP Reagent Kit | Alinity | ABBOTT GMBH |
| 21 | 00380740012816 | 7D54-21 | 07D5421 | Albumin BCP | ARCHITECT | ABBOTT LABORATORIES |
| 22 | 15099590625719 | 442765 | 442765 | Albumin Reagent (ALB 2 x 300) | Synchron | BECKMAN COULTER, INC. |
| 23 | 15099590233341 | 467858 | 467858 | SYNCHRON Systems Albumin Reagent | Synchron | BECKMAN COULTER, INC. |
| 24 | 08058056681980 | C22856 | C22856 | The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the dete The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only. | Albumin BCP (6x50 mL) | SENTINEL CH. SPA |
| 25 | 08058056681973 | C22855 | C22855 | The Albumin BCP (6x20 mL) assay is an in vitro diagnostic test used for the dete The Albumin BCP (6x20 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only. | Albumin BCP (6x20 mL) | SENTINEL CH. SPA |