No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00817238011643 | 98232 | Cardiac Calibration Verifiers for Beckman Systems | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Calibration Verifiers for Beckman Systems | |
2 | 00817238011605 | 91490 | Cardiac Control Complete +TnT level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Control Complete +TnT level 1 | |
3 | 00817238011551 | 83638 | Vitamin D | Vitamin D | ||||
4 | 00817238011391 | R82042 | BUN Rate Reagent | CDG | Chromatography Separation/Zimmerman 17-Ketogenic Steroids | 1 | BUN Rate Reagent | |
5 | 00817238011322 | 85621 | Hemoglobin A1C Reagent | LCP | Assay, Glycosylated Hemoglobin | 2 | Hemoglobin A1C Reagent | |
6 | 00817238011117 | R85168 | Phosphorous Reagent | Phosphorous Reagent | ||||
7 | 00817238011032 | R85321 | Fructosamine Calibrator | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Fructosamine Calibrator | |
8 | 00817238010486 | 97201 | DipStrip Urinalysis Control Bi-Level | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | DipStrip Urinalysis Control Bi-Level | |
9 | 00817238010394 | 91819 | DIABETES CONTROL SAMPLE PACK | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | DIABETES CNTL, Smpl, 1x2x0.5mL | |
10 | 00817238010271 | 91501 | LIQUID QC LIPID CONTROL LEVEL | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID QC LIPID CONTROL LEVEL | |
11 | 00817238010196 | 91102 | ImmuTROL Serum Protein Contrl Level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | ImmuTROL Serum Protein Contrl Level 2 | |
12 | 00817238010103 | 91303 | Tumor Marker Control level 3 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tumor Marker Control level 3 | |
13 | 00817238011582 | 93221 | WHOLE BLD VOLATILES CONTROL LEVEL 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | WHOLE BLD VOLATILES CONTROL LEVEL 1 | |
14 | 00817238010783 | 85962 | Hemoglobin A1c Calibrators | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Hemoglobin A1c Calibrators | |
15 | 00817238010028 | 98602 | LiniCAL Cardiac CalVer for Abbott Systems, Level ALiniCAL Cardiac CalVer for Abb LiniCAL Cardiac CalVer for Abbott Systems, Level ALiniCAL Cardiac CalVer for Abbott Systems, Level BLiniCAL Cardiac CalVer for Abbott Systems, Level CLiniCAL Cardiac CalVer for Abbott Systems, Level DLiniCAL Cardiac CalVer for Abbott Systems, Level E | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac CalVer for Abbott Systems, Level A-E | |
16 | 00817238011575 | 93212 | WHOLE BLOOD ETHANOL CONTROL LEVEL 2 | DKC | Alcohol Control Materials | 1 | WHOLE BLOOD ETHANOL CONTROL LEVEL 2 | |
17 | 00817238011568 | 93211 | WHOLE BLOOD ETHANOL CONTROL LEVEL1 | DKC | Alcohol Control Materials | 1 | WHOLE BLOOD ETHANOL CONTROL LEVEL1 | |
18 | 00817238011513 | 91444 | LQC Cardiac Control CS, Tri-level kit | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LQC Cardiac Control CS, Tri-level kit | |
19 | 00817238010479 | 95505 | Alcohol/Ammonia Control Bi-level | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alcohol/Ammonia Control Bi-level | |
20 | 00817238010417 | 94102 | Immunoassay Control Level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Immunoassay Control Level 2 | |
21 | 00817238010288 | 91502 | LIQUID QC LIPID CONTROL LEVEL 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID QC LIPID CONTROL LEVEL 2 | |
22 | 00817238010233 | 91203 | hsCRP Serum Protein Control Level 3 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | hsCRP Serum Protein Control Level 3 | |
23 | 00817238010219 | 91201 | hsCRP Serum Protein Control Level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | hsCRP Serum Protein Control Level 1 | |
24 | 00817238010202 | 91103 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | ImmuTROL Serum Protein Contrl Level 3 | ||
25 | 00817238010172 | 91105 | ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3) | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3) | |
26 | 00817238010042 | 91474 | Cardiac Marker Control VS Tri-Levels | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Marker Control VS | |
27 | 00817238011636 | 98505 | Cardiac Calibration Verifiers for Roche Systems | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Calibration Verifiers for Roche Systems | |
28 | 00817238011148 | R85411 | Glucose UV REAGENT | CFR | Hexokinase, Glucose | 2 | Glucose UV REAGENT | |
29 | 00817238011056 | 85550 | hsCRP Wide Range Reagent | DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | hsCRP Wide Range Reagent | |
30 | 00817238010462 | 95502 | Alcohol/Ammonia Control level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alcohol/Ammonia Control level 2 | |
31 | 00817238010455 | 95501 | Alcohol/Ammonia Control level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alcohol/Ammonia Control level 1 | |
32 | 00817238010189 | 91101 | ImmuTROL Serum Protein Contrl Level 1 | ImmuTROL Serum Protein Contrl Level 1 | ||||
33 | 00817238010127 | 91302 | Tumor Marker Control level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tumor Marker Control level 2 | |
34 | 00817238010110 | 91301 | Tumor Marker Control level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tumor Marker Control level 1 | |
35 | 00817238010066 | 91482 | Cardiac Marker Control +TnI Level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Marker Complete Level 2 | |
36 | 00817238011612 | 91491 | Cardiac Control Complete +TnT level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Control Complete +TnT level 2 | |
37 | 00817238010677 | 98502 | Protein 2 Calibration Verifier Set for the Roche Integra | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Protein 2 Calibration Verifier Set for the Roche Integra | |
38 | 00817238010578 | R83082 | Assay Control Serum Level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Assay Control Serum Level 1 | |
39 | 00817238010523 | R85528 | LIPID CALIBRATOR, LYOPHILIZED | LIPID CALIBRATOR, LYOPHILIZED | ||||
40 | 00817238010493 | 97202 | DropStrip Urinalysis Control Bi-Level | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | DropStrip Urinalysis Control Bi-Level | |
41 | 00817238010448 | 94109 | Tri-Level Immunoassay Control Minipack | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tri-Level Immunoassay Control Minipack | |
42 | 00817238010424 | 94103 | Immunoassay Control Level 3 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Immunoassay Control Level 3 | |
43 | 00817238010387 | 91815 | DIABETES CONTROL BI-LEVEL | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | DIABETES CNTL, Bi-L | |
44 | 00817238010226 | 91202 | hsCRP Serum Protein Control Level 2 | hsCRP Serum Protein Control Level 2 | ||||
45 | 00817238010158 | 91309 | Tumor Marker Control Tri-level | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tumor Marker Control Tri-level | |
46 | 00817238010141 | 91104 | ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3) | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3) | |
47 | 00817238011315 | 98303 | Protein 3 Calibration Verifier set for the BCI AU | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Protein 3 Calibration Verifier set for the BCI AU | |
48 | 00817238010684 | 98503 | Protein 3 Calibration verifier Set for the Roche Integra | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Protein 3 Calibration verifier Set for the Roche Integra | |
49 | 00817238010516 | 97204 | DipScopics Urinalysis Control Bi-Level | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | DipScopics Urinalysis Control Bi-Level | |
50 | 00817238010240 | 91204 | hsCRP Serum Protein Control Tri-Level | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | hsCRP Serum Protein Control Tri-Level |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 17350066140579 | 660-20 | AMH Control | FUJIREBIO DIAGNOSTICS AB | ||
2 | 17350066140531 | 240-20 | Lung Marker Control | FUJIREBIO DIAGNOSTICS AB | ||
3 | 17350066140524 | 360-20 | Mesothelin Control | FUJIREBIO DIAGNOSTICS AB | ||
4 | 17350066140043 | 108-20 | Tumor Marker Control | FUJIREBIO DIAGNOSTICS AB | ||
5 | 17290018739072 | FG00004 | The Performance Verification Kit contains a set of serum-based quantitative samp The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only. | Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP | MEMED DIAGNOSTICS LTD | |
6 | 15099590233877 | 657365 | 657365 | SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum | Synchron | BECKMAN COULTER, INC. |
7 | 15099590228743 | 465939 | 465939 | SYNCHRON Systems 125 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
8 | 15099590227357 | 450163 | 450163 | Vigil Serology Control Level 2 | Vigil | BECKMAN COULTER, INC. |
9 | 15099590227333 | 450164 | 450164 | Vigil Serology Control Level 3 | Vigil | BECKMAN COULTER, INC. |
10 | 15099590227326 | 465440 | 465440 | Vigil Serology Control Level C | Vigil | BECKMAN COULTER, INC. |
11 | 15099590227258 | 465912 | 465912 | SYNCHRON Systems 75 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
12 | 15099590227234 | 465914 | 465914 | SYNCHRON Systems 20 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
13 | 15099590226916 | 450120 | 450120 | Vigil Protein Control Level 1 | Vigil | BECKMAN COULTER, INC. |
14 | 15099590225384 | 465290 | 465290 | Immunochemistry Systems Level 1 Urine Protein Control | IMMAGE | BECKMAN COULTER, INC. |
15 | 15099590224158 | 465300 | 465300 | Immunochemistry Systems Level 2 Urine Protein Control | IMMAGE | BECKMAN COULTER, INC. |
16 | 15099590223045 | 450125 | 450125 | Vigil Protein Control Level 2 | Vigil | BECKMAN COULTER, INC. |
17 | 15099590222925 | 465980 | 465980 | Vigil Lipid Control Level 2 | Vigil | BECKMAN COULTER, INC. |
18 | 15099590222918 | 465981 | 465981 | Vigil Lipid Control Level 3 | Vigil | BECKMAN COULTER, INC. |
19 | 15099590222901 | 465982 | 465982 | Vigil Lipid Control Level 4 | Vigil | BECKMAN COULTER, INC. |
20 | 15099590222611 | 450130 | 450130 | Vigil Protein Control Level 3 | Vigil | BECKMAN COULTER, INC. |
21 | 15099590222604 | 450162 | 450162 | Vigil Serology Control Level 1 | Vigil | BECKMAN COULTER, INC. |
22 | 15099590222000 | 474988 | 474988 | SYNCHRON Systems OP 300 Low Urine Control | Synchron | BECKMAN COULTER, INC. |
23 | 15099590221997 | 474991 | 474991 | SYNCHRON Systems OP 300 High Urine Control | Synchron | BECKMAN COULTER, INC. |
24 | 15099590221270 | 469905 | 469905 | Vigil Lipid Control Level 1 | Vigil | BECKMAN COULTER, INC. |
25 | 10851290002567 | CVC 223 | CVC 223 | RNA Medical CVC 223 Multi-Level Carton | RNA Medical | RNA MEDICAL DIVISION |
26 | 10851290002550 | CVC 123 | CVC 123 | Carton for CVC 123 | RNA Medical | RNA MEDICAL DIVISION |
27 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
28 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
29 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
30 | 10758750008322 | 1009406 | 1009406 | VITROS Immunodiagnostic Products RE Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
31 | 10758750006977 | 6801751 | 6801751 | VITROS Chemistry Products %A1c Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
32 | 10758750006960 | 6801750 | 6801750 | VITROS Chemistry Products %A1c Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
33 | 10758750002702 | 6802349 | 6802349 | VITROS Chemistry Products dTIBC Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
34 | 10758750002696 | 6802348 | 6802348 | VITROS Chemistry Products dTIBC Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
35 | 10627966005305 | C5003-2 | C5003-2 | RAMP® Cardiac Controls - Level 2 | RESPONSE BIOMEDICAL CORP | |
36 | 10627966005299 | C5003-1 | C5003-1 | RAMP® Cardiac Controls - Level 1 | RESPONSE BIOMEDICAL CORP | |
37 | M52551410 | 5141 | Hi Res Protein Marker | HELENA LABORATORIES CORPORATION | ||
38 | M52551360 | 5136 | SPE Control (1 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
39 | M52550690 | 5069 | LipoTrol (5 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
40 | M52534250 | 3425 | SPE Abnormal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
41 | M52534240 | 3424 | SPE Normal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
42 | M52518110 | 1811 | V8 SP Abnormal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
43 | M52518100 | 1810 | V8 SP Normal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
44 | M52518050 | 1805 | V8 Serum Protein SPE Kit (500 tests) | HELENA LABORATORIES CORPORATION | ||
45 | M52514790 | 1479 | Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays | HELENA LABORATORIES CORPORATION | ||
46 | 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. |
47 | 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. |
48 | 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. |
49 | 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. | |
50 | 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. |