No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 07333066022307 | 34-2317-93 | 34-2317-93 | Phadia Maintenance Solution Small | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Phadia Maintenance Solution Small |
2 | 07333066019994 | 83-0008-01 | 83-0008-01 | EliA APS Positive Control 250 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA APS Positive Control 250 |
3 | 07333066019987 | 83-0007-91 | 83-0007-91 | EliA APS Positive Control 100 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA APS Positive Control 100 |
4 | 07333066019970 | 83-0006-71 | 83-0006-71 | EliA Celiac Positive Control 250 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA Celiac Positive Control 250 |
5 | 07333066019963 | 34-2341-31 | 34-2341-31 | ImmunoCAP Specific IgE Control H | DHB | System, test, radioallergosorbent (rast) immunological | 2 | ImmunoCAP Specific IgE Control H |
6 | 07333066019949 | 34-2341-11 | 34-2341-11 | ImmunoCAP Specific IgE Control L | DHB | System, test, radioallergosorbent (rast) immunological | 2 | ImmunoCAP Specific IgE Control L |
7 | 07333066019857 | 34-2325-31 | 34-2325-31 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent |
8 | 07333066019840 | 34-2316-11 | 34-2316-11 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent |
9 | 07333066019826 | 34-2294-41 | 34-2294-41 | ImmunoCAP Specific IgG Conjugate | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Specific IgG Conjugate |
10 | 07333066019628 | 10-9414-01 | 10-9414-01 | Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for t Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for the ImmunoCAP Thyroid Peroxidase method. | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH |
11 | 07333066014807 | DECC055390 | DECC055390 | EliA GliadinDP IgG Well | MST | Antibodies, gliadin | 2 | EliA GliadinDP IgG Well |
12 | 07333066017549 | 14-6016-01 | 14-6016-01 | ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee | PUW | System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee |
13 | 07333066017532 | 14-6015-01 | 14-6015-01 | ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee | PUW | System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee |
14 | 07333066014852 | DECC056490 | DECC056490 | EliA M2 Well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | EliA M2 Well |
15 | 07333066014746 | DECC055310 | DECC055310 | EliA ß2-Glycoprotein I IgA Well | MSV | System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | EliA ß2-Glycoprotein I IgA Well |
16 | 07333066014692 | DECC055200 | DECC055200 | EliA Gliadin IgG Well | MST | Antibodies, gliadin | 2 | EliA Gliadin IgG Well |
17 | 07333066013138 | 83-0008-51 | 83-0008-51 | EliA IgM Conjugate 200 | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | 2 | EliA IgM Conjugate 200 |
18 | 07333066013077 | 83-0007-21 | 83-0007-21 | EliA Celiac Positive Control 100 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA Celiac Positive Control 100 |
19 | 07333066013060 | 83-0007-11 | 83-0007-11 | EliA CCP Positive Control 100 | NHX | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) | 2 | EliA CCP Positive Control 100 |
20 | 07333066012841 | 83-0003-41 | 83-0003-41 | EliA IgA Curve Control Strip | MVM | Autoantibodies, endomysial(tissue transglutaminase) | 2 | EliA IgA Curve Control Strip |
21 | 07333066012780 | 83-0002-81 | 83-0002-81 | EliA IgA Conjugate | MVM | Autoantibodies, endomysial(tissue transglutaminase) | EliA IgA Conjugate | |
22 | 07333066011615 | 34-2273-31 | 34-2273-31 | ImmunoCAP Specific IgG Curve Control Strip | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Specific IgG Curve Control Strip |
23 | 07333066010496 | 14-5341-01 | 14-5341-01 | ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut |
24 | 07333066009902 | 14-5304-10 | 14-5304-10 | ImmunoCAP Antigen RGm24, Stachybotrys atra | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Antigen RGm24, Stachybotrys atra |
25 | 07333066009841 | 14-5301-10 | 14-5301-10 | ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST |
26 | 07333066009193 | 14-5254-10 | 14-5254-10 | ImmunoCAP Allergen f335, Lupine seed | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen f335, Lupine seed |
27 | 07333066009094 | 14-5249-10 | 14-5249-10 | ImmunoCAP Rare Allergen Rf332, Mint | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rf332, Mint |
28 | 07333066008424 | 14-5209-10 | 14-5209-10 | ImmunoCAP Allergen Rf313, Anchovy | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf313, Anchovy |
29 | 07333066008363 | 14-5206-10 | 14-5206-10 | ImmunoCAP Allergen Rfx21, Fruits | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rfx21, Fruits |
30 | 07333066008288 | 14-5202-10 | 14-5202-10 | ImmunoCAP Allergen Rm208, Chaetomium globosum | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rm208, Chaetomium globosum |
31 | 07333066008059 | 14-5189-10 | 14-5189-10 | ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid |
32 | 07333066007953 | 14-5183-10 | 14-5183-10 | ImmunoCAP Allergen Rtx10, Tree pollen | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rtx10, Tree pollen |
33 | 07333066007496 | 14-5139-10 | 14-5139-10 | ImmunoCAP Rare Allergen Rf298, Tragacanth | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rf298, Tragacanth |
34 | 07333066006925 | 14-5086-10 | 14-5086-10 | ImmunoCAP Allergen Rf212, Mushroom (champignon) | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf212, Mushroom (champignon) |
35 | 07333066006642 | 14-5065-10 | 14-5065-10 | ImmunoCAP Allergen Rf221, Coffee | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf221, Coffee |
36 | 07333066006628 | 14-5064-10 | 14-5064-10 | ImmunoCAP Allergen Rf268, Clove | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf268, Clove |
37 | 07333066006574 | 14-5060-10 | 14-5060-10 | ImmunoCAP Allergen Rf291, Cauliflower | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf291, Cauliflower |
38 | 07333066006352 | 14-5044-10 | 14-5044-10 | ImmunoCAP Allergen Rf271, Anise | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf271, Anise |
39 | 07333066006147 | 14-5026-10 | 14-5026-10 | ImmunoCAP Allergen wx209, Ambrosia sp. | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen wx209, Ambrosia sp. |
40 | 07333066005768 | 14-4990-01 | 14-4990-01 | ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy |
41 | 07333066005713 | 14-4983-01 | 14-4983-01 | ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort |
42 | 07333066005638 | 14-4972-01 | 14-4972-01 | ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass |
43 | 07333066005539 | 14-4963-01 | 14-4963-01 | ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut |
44 | 07333066005508 | 14-4960-01 | 14-4960-01 | ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach |
45 | 07333066005386 | 14-4950-10 | 14-4950-10 | ImmunoCAP Allergen Rw23, Yellow dock | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rw23, Yellow dock |
46 | 07333066004556 | 14-4843-01 | 14-4843-01 | ImmunoCAP Allergen f299, Sweet chestnut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f299, Sweet chestnut |
47 | 07333066004488 | 14-4836-01 | 14-4836-01 | ImmunoCAP Allergen f203, Pistachio | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f203, Pistachio |
48 | 07333066004327 | 14-4820-01 | 14-4820-01 | ImmunoCAP Allergen f207, Clam | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f207, Clam |
49 | 07333066004303 | 14-4818-01 | 14-4818-01 | ImmunoCAP Allergen f284, Turkey meat | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f284, Turkey meat |
50 | 07333066003801 | 14-4434-01 | 14-4434-01 | ImmunoCAP Allergen f254, Plaice | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f254, Plaice |
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. |