| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00850011135440 | 508ro | VALIDATE Growth Hormone IVD Control | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate | |
| 2 | 00850011135402 | 510mm | Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate | |
| 3 | 00850011135396 | 608mm | Validate ISX Multiple-type clinical chemistry analyte IVD, control | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate | |
| 4 | 00859110005999 | 701sa | 701sa | Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 5 | 00859110005982 | 701db | 701db | Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 6 | 00859110005975 | 701bc | 701bc | Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 7 | 00859110005968 | 701au | 701au | Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 8 | 00859110005951 | 607ro | 607ro | Validate Whole Blood Glucose (WBG) is intended for the quantitative determinatio Validate Whole Blood Glucose (WBG) is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 9 | 00859110005944 | 605to | 605to | Validate HbA1c is intended for the quantitative determination of Calibration Ver Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 10 | 00859110005937 | 605 | 605 | Validate HbA1c is intended for the quantitative determination of Calibration Ver Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 11 | 00859110005920 | 603ro | 603ro | Validate SP3 is intended for the quantitative determination of Calibration Verif Validate SP3 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 12 | 00859110005913 | 602re | 602re | Validate SP2 is intended for the quantitative determination of Calibration Verif Validate SP2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 13 | 00859110005906 | 602bc | 602bc | Validate SP2 is intended for the quantitative determination of Calibration Verif Validate SP2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 14 | 00859110005890 | 601ro | 601ro | Validate SP1 is intended for the quantitative determination of Calibration Verif Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 15 | 00859110005883 | 601bcs | 601bcs | Validate SP1 is intended for the quantitative determination of Calibration Verif Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 16 | 00859110005876 | 601bc | 601bc | Validate SP1 is intended for the quantitative determination of Calibration Verif Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 17 | 00859110005869 | 507ro | 507ro | Validate LP2 is intended for the quantitative determination of Calibration Verif Validate LP2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 18 | 00859110005852 | 506vt | 506vt | Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 19 | 00859110005845 | 506ab | 506ab | Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 20 | 00859110005838 | 506 | 506 | Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 21 | 00859110005821 | 504re | 504re | Validate Fertility 2 is intended for the quantitative determination of Calibrati Validate Fertility 2 is intended for the quantitative determination of Calibration Verification/Linearity of on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 22 | 00859110005814 | 502re | 502re | Validate Fertility 1 is intended for the quantitative determination of Calibrati Validate Fertility 1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 23 | 00859110005807 | 501vt | 501vt | Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 24 | 00859110005791 | 501sa | 501sa | Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 25 | 00859110005784 | 501ro | 501ro | Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 26 | 00859110005777 | 501db | 501db | Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 27 | 00859110005760 | 501bc | 501bc | Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 28 | 00859110005753 | 501au | 501au | Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 29 | 00859110005746 | 501ab | 501ab | Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 30 | 00859110005739 | 407sa | 407sa | Validate Tumor Markers is intended for the quantitative determination of Calibra Validate Tumor Markers is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 31 | 00859110005722 | 407re | 407re | Validate Tumor Markers is intended for the quantitative determination of Calibra Validate Tumor Markers is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 32 | 00859110005715 | 406re | 406re | Validate PSA is intended for the quantitative determination of Calibration Verif Validate PSA is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 33 | 00859110005708 | 406bc | 406bc | Validate PSA is intended for the quantitative determination of Calibration Verif Validate PSA is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 34 | 00859110005692 | 405ro | 405ro | Validate High Sensitive Troponin is intended for the quantitative determination Validate High Sensitive Troponin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 35 | 00859110005685 | 404ro | 404ro | Validate hsCRP is intended for the quantitative determination of Calibration Ver Validate hsCRP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 36 | 00859110005678 | 403ro | 403ro | Validate PCT is intended for the quantitative determination of Calibration Verif Validate PCT is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 37 | 00859110005661 | 403ab | 403ab | Validate PCT is intended for the quantitative determination of Calibration Verif Validate PCT is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 38 | 00859110005654 | 402vt | 402vt | Validate CM2 is intended for the quantitative determination of Calibration Verif Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 39 | 00859110005647 | 402re | 402re | Validate CM2 is intended for the quantitative determination of Calibration Verif Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 40 | 00859110005630 | 402bc | 402bc | Validate CM2 is intended for the quantitative determination of Calibration Verif Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 41 | 00859110005623 | 402ab | 402ab | Validate CM2 is intended for the quantitative determination of Calibration Verif Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 42 | 00859110005616 | 401db | 401db | Validate CM1 is intended for the quantitative determination of Calibration Verif Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 43 | 00859110005609 | 401bc | 401bc | Validate CM1 is intended for the quantitative determination of Calibration Verif Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 44 | 00859110005593 | 401ab | 401ab | Validate CM1 is intended for the quantitative determination of Calibration Verif Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 45 | 00859110005586 | 308re | 308re | Validate Anemia is intended for the quantitative determination of Calibration Ve Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 46 | 00859110005579 | 308bc | 308bc | Validate Anemia is intended for the quantitative determination of Calibration Ve Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 47 | 00859110005562 | 307 | 307 | Validate Ferritin is intended for the quantitative determination of Calibration Validate Ferritin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Validate |
| 48 | 00859110005555 | 205ro | 205ro | Validate Body Fluids is intended for the quantitative determination of Calibrati Validate Body Fluids is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 49 | 00859110005531 | 203vt | 203vt | Validate IBC is intended for the quantitative determination of Calibration Verif Validate IBC is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| 50 | 00859110005524 | 203sd | 203sd | Validate IBC is intended for the quantitative determination of Calibration Verif Validate IBC is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Validate |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | M52551410 | 5141 | Hi Res Protein Marker | HELENA LABORATORIES CORPORATION | ||
| 2 | M52551360 | 5136 | SPE Control (1 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 3 | M52550690 | 5069 | LipoTrol (5 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
| 4 | M52534250 | 3425 | SPE Abnormal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 5 | M52534240 | 3424 | SPE Normal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 6 | M52518110 | 1811 | V8 SP Abnormal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 7 | M52518100 | 1810 | V8 SP Normal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 8 | M52518050 | 1805 | V8 Serum Protein SPE Kit (500 tests) | HELENA LABORATORIES CORPORATION | ||
| 9 | M52514790 | 1479 | Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays | HELENA LABORATORIES CORPORATION | ||
| 10 | 08718734961499 | Level 3 | 221.003.010 | CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
| 11 | 08718734961482 | Level 2 | 221.002.010 | CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
| 12 | 08718734961475 | Level 1 | 221.001.010 | CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
| 13 | 08718734961468 | 220.000.005 | CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451 | CueSee® VeriSTAT LVM | EUROTROL B.V. | |
| 14 | 08718734960928 | 183.000.005 | Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit. | Eurotrol | EUROTROL B.V. | |
| 15 | 08718734960911 | 179.003.010 | Eurotrol | EUROTROL B.V. | ||
| 16 | 08718734960898 | 179.002.010 | Eurotrol | EUROTROL B.V. | ||
| 17 | 08718734960874 | 179.001.010 | Eurotrol | EUROTROL B.V. | ||
| 18 | 08718734960805 | 267.000.005 | 267.000.005 | Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood g Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol® epoc® Calibration Verification Fluids is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol® epoc® Calibration Verification Fluids | EUROTROL B.V. |
| 19 | 08718734960799 | Level 6 | 266.006.010 | Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 6 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol epoc GAS-ISE Metabolites | EUROTROL B.V. |
| 20 | 08718734960775 | Level 3 | 266.003.010 | Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 3 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol epoc GAS-ISE Metabolites | EUROTROL B.V. |
| 21 | 08718734960751 | Level 2 | 266.002.010 | Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 2 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol epoc GAS-ISE Metabolites | EUROTROL B.V. |
| 22 | 08718734960737 | Level 1 | 266.001.010 | Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 1 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol epoc GAS-ISE Metabolites | EUROTROL B.V. |
| 23 | 08430793040587 | 724122 | The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celia The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgA Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. | Aptiva® Celiac Disease IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 24 | 08430793040525 | 724102 | The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celi The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celiac IgG Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgG Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. | Aptiva® Celiac Disease IgG Controls | INOVA DIAGNOSTICS, INC. | |
| 25 | 08426951346479 | 0003310350 | 00003310350 | Avox-4 CO-Oximeter Control Level 1, Level 2 and Level 3 | Avox-4 CO-Oximeter Control | INSTRUMENTATION LABORATORY COMPANY |
| 26 | 08426951346462 | 0003310300 | 00003310300 | Avox-4 CO-Oximeter Control, Level 3 | Avox-4 CO-Oximeter Control - L3 | INSTRUMENTATION LABORATORY COMPANY |
| 27 | 08426951346455 | 0003310200 | 00003310200 | Avox-4 CO-Oximeter Control, Level 2 | Avox-4 CO-Oximeter Control - L2 | INSTRUMENTATION LABORATORY COMPANY |
| 28 | 08426951346448 | 0003310100 | 00003310100 | Avox-4 CO-Oximeter Control, Level 1 | Avox-4 CO-Oximeter Control - L1 | INSTRUMENTATION LABORATORY COMPANY |
| 29 | 08426951293810 | 00044000103 | 00044000103 | ChemSTAT System Evaluator 3, 10 ampoules x 1.8 mL | ChemSTAT System Evaluator 3 | INSTRUMENTATION LABORATORY COMPANY |
| 30 | 08426951293803 | 00044000102 | 00044000102 | ChemSTAT System Evaluator 2, 10 ampoules x 1.8 mL | ChemSTAT System Evaluator 2 | INSTRUMENTATION LABORATORY COMPANY |
| 31 | 08426951293797 | 00044000101 | 00044000101 | ChemSTAT System Evaluator 1, 10 ampoules x 1.8 mL | ChemSTAT System Evaluator 1 | INSTRUMENTATION LABORATORY COMPANY |
| 32 | 08426951293780 | 00044001515 | 00044001515 | GEM ChemSTAT PVP1-5, 5 levels x 5 ampoules x 1.8 mL | GEM ChemSTAT PVP 1-5 | INSTRUMENTATION LABORATORY COMPANY |
| 33 | 08426951293773 | 00044000140 | 00044000140 | GEM ChemSTAT CVP 4, 10 ampoules x 1.8 mL | GEM ChemSTAT CVP 4 | INSTRUMENTATION LABORATORY COMPANY |
| 34 | 08426951293766 | 00044000130 | 00044000130 | GEM ChemSTAT CVP 3, 10 ampoules x 1.8 mL | GEM ChemSTAT CVP 3 | INSTRUMENTATION LABORATORY COMPANY |
| 35 | 08426951293759 | 00044000125 | 00044000125 | GEM ChemSTAT CVP 2, 10 ampoules x 1.8 mL | GEM ChemSTAT CVP 2 | INSTRUMENTATION LABORATORY COMPANY |
| 36 | 08426951293742 | 00044000115 | 00044000115 | GEM ChemSTAT CVP 1, 10 ampoules x 1.8 mL | GEM ChemSTAT CVP 1 | INSTRUMENTATION LABORATORY COMPANY |
| 37 | 08426950573654 | 00025000103 | 00025000103 | GEM System Evaluator 3 | GEM System Evaluator 3 | INSTRUMENTATION LABORATORY COMPANY |
| 38 | 08426950573647 | 00025000102 | 00025000102 | GEM System Evaluator 2 | GEM System Evaluator 2 | INSTRUMENTATION LABORATORY COMPANY |
| 39 | 08426950573630 | 00025000101 | 00025000101 | GEM System Evaluator 1 | GEM System Evaluator 1 | INSTRUMENTATION LABORATORY COMPANY |
| 40 | 08426950573005 | 00003314250 | 00003314250 | Multi-4 CO-Oximeter Control, Level 2 | Multi-4 CO-Oximeter Control, Level 2 | INSTRUMENTATION LABORATORY COMPANY |
| 41 | 08426950511519 | 00024001515 | 00024001515 | PVP Set | IL PVP | INSTRUMENTATION LABORATORY COMPANY |
| 42 | 08426950485704 | 00025000145 | 00025000145 | GEM CVP (Calibration Valuation Product) 5 tBili | GEM CVP (Calibration Valuation Product) 5 tBili | INSTRUMENTATION LABORATORY COMPANY |
| 43 | 08426950453161 | 00003313250 | 00003313250 | Multi-4 CO-Oximeter Control, Level 3 | Multi-4 CO-Oximeter Control, Level 3 | INSTRUMENTATION LABORATORY COMPANY |
| 44 | 08426950453154 | 00003315250 | 00003315250 | Multi-4 CO-Oximeter Control, Level 1 | Multi-4 CO-Oximeter Control, Level 1 | INSTRUMENTATION LABORATORY COMPANY |
| 45 | 08426950440680 | 00025000115 | 00025000115 | GEM CVP (Calibration Valuation Product) 1 with CO-OX | GEM CVP (Calibration Valuation Product) 1 with CO-OX | INSTRUMENTATION LABORATORY COMPANY |
| 46 | 08426950440673 | 00025000125 | 00025000125 | GEM CVP (Calibration Valuation Product) 2 with CO-OX | GEM CVP (Calibration Valuation Product) 2 with CO-OX | INSTRUMENTATION LABORATORY COMPANY |
| 47 | 08426950358763 | 00024001814 | 00024001814 | GEM CVP (Calibration Validation Product) Level 4 | GEM CVP (Calibration Validation Product) Level 4 | INSTRUMENTATION LABORATORY COMPANY |
| 48 | 08426950358756 | 00024001813 | 00024001813 | GEM CVP (Calibration Validation Product) Level 3 | GEM CVP (Calibration Validation Product) Level 3 | INSTRUMENTATION LABORATORY COMPANY |
| 49 | 08426950358749 | 00024001812 | 00024001812 | GEM CVP (Calibration Validation Product) Level 2 | GEM CVP (Calibration Validation Product) Level 2 | INSTRUMENTATION LABORATORY COMPANY |
| 50 | 08426950358732 | 00024001811 | 00024001811 | GEM CVP (Calibration Validation Product) Level 1 | GEM CVP (Calibration Validation Product) Level 1 | INSTRUMENTATION LABORATORY COMPANY |