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 | 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. | CJW | Bromcresol Purple Dye-Binding, Albumin | 2 | Albumin BCP (6x20 mL) |
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 | 00812277030068 | 2762-32702 | 2762-32702 | Curaplex Control Solution 2/BT | Curaplex | BOUND TREE MEDICAL, LLC |
2 | 00811727015594 | L7597-CTL | L7597-CTL | Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitorin Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitoring the quality control of results obtained with the Pointe Lipoprotein(a) Assay reagents by turbidimetry. For in vitro diagnostic use. | Pointe Lipoprotein (a) Control Set | POINTE SCIENTIFIC, INC. |
3 | 00810042683181 | 702012 | 702012 | HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
4 | 00810042683174 | 18003155 | hCG Low Positive/Negative Urine 2x5mL Kitbox | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
5 | 00810042683129 | 2110005 | 18000347 | CenMed hCG URINE Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
6 | 00810042683112 | 2110007 | 18000346 | CenMed hCG URINE Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
7 | 00810042682962 | 2122015 | 18000698 | CenMed hCG Serum Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
8 | 00810042682948 | 2122017 | 18000697 | CenMed hCG Serum Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
9 | 00810042682900 | Custom QC31 | PREGNANCY SKREEN Custom hCG Serum 4mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
10 | 00810042682894 | Custom QC30 | PREGNANCY SKREEN Custom hCG Serum 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
11 | 00810042681415 | Custom QC25 | PREGNANCY SKREEN Custom hCG Liquid Urine 50mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
12 | 00810042681408 | Custom QC24 | PREGNANCY SKREEN Custom hCG Liquid Urine 20mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
13 | 00810042681392 | Custom QC23 | PREGNANCY SKREEN Custom hCG Liquid Urine 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
14 | 00810042681385 | Custom QC22 | PREGNANCY SKREEN Custom hCG Liquid Urine 2mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
15 | 00810042681347 | Custom QC18 | PREGNANCY SKREEN Custom hCG Liquid Urine 4cc kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
16 | 00810042681156 | 18030367 | 18030367 | HCG Urine 2x4mL dropper Kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
17 | 00810042681095 | 18000656 | 18000656 | CONSULT HCG 4mL KIT | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
18 | 00810042681088 | 18000443 | 18000443 | Cardinal HCG 4mL Kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
19 | 00810042681071 | 18000442 | 18000442 | ALERE HCG 4mL KIT | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
20 | 00804084000150 | GCS0104 | For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of b For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions contains a known amount of glucose that reacts with the test strips. | IDEAL LIFE Control Solution Level II | IDEAL LIFE INC | |
21 | 00804084000143 | AGS-1112 | IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips) | IDEAL LIFE INC | ||
22 | 00793150629794 | IGM-1003A | INFCN003L | Glucose Control Solution | Oh’Care Lite Glucose Control Solution | OSANG HEALTHCARE CO., LTD. |
23 | 00793150629763 | IGM-1003A | Blood Glucose Monitoring System Kit | Oh’Care Lite Blood Glucose Monitoring System Kit | OSANG HEALTHCARE CO., LTD. | |
24 | 00763924540105 | MD540 | Lipid and Glucose Measuring System | LipidPlus® Glucose Test Strips | JANT PHARMACAL CORPORATION | |
25 | 00748349000717 | 10001 | 10001 | Glucose Pilot - The Complete Glucose Monitoring System | Glucose Pilot | SYNTRON BIORESEARCH, INC. |
26 | 00742860100178 | 176 | 176 | OSOM H. Pylori Control Kit | SEKISUI DIAGNOSTICS, LLC | |
27 | 00742860100093 | 138 | 138 | HCG SERUM CONTROL KIT | SEKISUI DIAGNOSTICS, LLC | |
28 | 00732671109422 | 942-2 | 942-2 | Control Solution - L2 (High) | Pip | AMITY HOLDINGS, LLC |
29 | 00732671009425 | 942-1 | 942-1 | Control Solution - L1 (low) | Pip | AMITY HOLDINGS, LLC |
30 | 00732671009401 | 940 | 940 | Blood Glucose Test Meter | Pip | AMITY HOLDINGS, LLC |
31 | 00699073704320 | 70432 | 70432 | FreeStyle Control Solution | FreeStyle | ABBOTT DIABETES CARE INC |
32 | 00699073140029 | 14002 | 14002 | FreeStyle Control Solution | FreeStyle | ABBOTT DIABETES CARE INC |
33 | 00695684781026 | 78102 | AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStri AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStrip® HB Hemoglobin (Hb) Meter. | AIMSTRIP HEMOGLOBIN OPTICAL VERIFIERS | GERMAINE LABORATORIES, INC | |
34 | 00695684775124 | ILM-0001A | blood glucose meter and test strip control solution-level 1,2,3 | AimStrip Tandem Glucose control solution | OSANG HEALTHCARE CO., LTD. | |
35 | 00695684774127 | ILM-0001A | Lipid measuring meter and Triglycerides test strip control solution level 1,2 | AimStrip Tandem Total Triglycerides Control Solution | OSANG HEALTHCARE CO., LTD. | |
36 | 00695684773120 | ILM-0001A | Lipid measuring meter and Total Cholesterol test strip control solution level 1,2 | AimStrip Tandem Total Cholesterol Control Solution | OSANG HEALTHCARE CO., LTD. | |
37 | 00695684773014 | ILM-0001A | Lipid and Glucose Measuring System | AimStrip Tandem Lipid Profile and glucose measuring system | OSANG HEALTHCARE CO., LTD. | |
38 | 00695684373122 | 37312 | Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test St Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test Strips & meter for testing blood glucose levels | AIMSTRIP PLUS, GLUCOSE CONTROL SOLUTION | GERMAINE LABORATORIES, INC | |
39 | 00695684131128 | 13112 | Ketone controls for use with ketone tests, 1 Positive and 1 Negative | KETONE SERUM CONTROLS | GERMAINE LABORATORIES, INC | |
40 | 00682607571017 | G117-108 | 757101 | Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Voice Blood Glucose Monitoring System | ACON LABORATORIES, INC. |
41 | 00682607558315 | G125-12L | Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 | On Call Pro Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
42 | 00682607558117 | G115-107 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Vivid Pal Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
43 | 00682607557325 | G125-12D | Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 | On Call Express Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
44 | 00682607557158 | G115-10D | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
45 | 00682607556311 | G125-122 | Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2 | On Call Vivid Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
46 | 00682607556113 | G115-102 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Vivid Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
47 | 00682607550128 | G115-10S | 755012 | Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Mobile Blood Glucose Monitoring System | ACON LABORATORIES, INC. |
48 | 00682607535316 | G123-311 | Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2 | On Call Plus Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
49 | 00682607535118 | G113-111 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Plus Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
50 | 00682607200023 | C122-3041 | 2mL bottles of Level 0, Level 1, Level 2 | Mission Plus Hemoglobin (Hb) Control Solution Kit | ACON LABORATORIES, INC. |