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 | 07333066019963 | 34-2341-31 | 34-2341-31 | ImmunoCAP Specific IgE Control H | DHB | System, test, radioallergosorbent (rast) immunological | 2 | ImmunoCAP Specific IgE Control H |
5 | 07333066019949 | 34-2341-11 | 34-2341-11 | ImmunoCAP Specific IgE Control L | DHB | System, test, radioallergosorbent (rast) immunological | 2 | ImmunoCAP Specific IgE Control L |
6 | 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 |
7 | 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 |
8 | 07333066019826 | 34-2294-41 | 34-2294-41 | ImmunoCAP Specific IgG Conjugate | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Specific IgG Conjugate |
9 | 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 |
10 | 07333066014807 | DECC055390 | DECC055390 | EliA GliadinDP IgG Well | MST | Antibodies, gliadin | 2 | EliA GliadinDP IgG Well |
11 | 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 |
12 | 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 |
13 | 07333066014852 | DECC056490 | DECC056490 | EliA M2 Well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | EliA M2 Well |
14 | 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 |
15 | 07333066014692 | DECC055200 | DECC055200 | EliA Gliadin IgG Well | MST | Antibodies, gliadin | 2 | EliA Gliadin IgG Well |
16 | 07333066013138 | 83-0008-51 | 83-0008-51 | EliA IgM Conjugate 200 | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | 2 | EliA IgM Conjugate 200 |
17 | 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 |
18 | 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 |
19 | 07333066012841 | 83-0003-41 | 83-0003-41 | EliA IgA Curve Control Strip | MVM | Autoantibodies, endomysial(tissue transglutaminase) | 2 | EliA IgA Curve Control Strip |
20 | 07333066012780 | 83-0002-81 | 83-0002-81 | EliA IgA Conjugate | MVM | Autoantibodies, endomysial(tissue transglutaminase) | EliA IgA Conjugate | |
21 | 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 |
22 | 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 |
23 | 07333066009902 | 14-5304-10 | 14-5304-10 | ImmunoCAP Antigen RGm24, Stachybotrys atra | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Antigen RGm24, Stachybotrys atra |
24 | 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 |
25 | 07333066009193 | 14-5254-10 | 14-5254-10 | ImmunoCAP Allergen f335, Lupine seed | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen f335, Lupine seed |
26 | 07333066009094 | 14-5249-10 | 14-5249-10 | ImmunoCAP Rare Allergen Rf332, Mint | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rf332, Mint |
27 | 07333066008424 | 14-5209-10 | 14-5209-10 | ImmunoCAP Allergen Rf313, Anchovy | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf313, Anchovy |
28 | 07333066008363 | 14-5206-10 | 14-5206-10 | ImmunoCAP Allergen Rfx21, Fruits | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rfx21, Fruits |
29 | 07333066008288 | 14-5202-10 | 14-5202-10 | ImmunoCAP Allergen Rm208, Chaetomium globosum | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rm208, Chaetomium globosum |
30 | 07333066008059 | 14-5189-10 | 14-5189-10 | ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid |
31 | 07333066007953 | 14-5183-10 | 14-5183-10 | ImmunoCAP Allergen Rtx10, Tree pollen | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rtx10, Tree pollen |
32 | 07333066007496 | 14-5139-10 | 14-5139-10 | ImmunoCAP Rare Allergen Rf298, Tragacanth | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rf298, Tragacanth |
33 | 07333066006925 | 14-5086-10 | 14-5086-10 | ImmunoCAP Allergen Rf212, Mushroom (champignon) | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf212, Mushroom (champignon) |
34 | 07333066006642 | 14-5065-10 | 14-5065-10 | ImmunoCAP Allergen Rf221, Coffee | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf221, Coffee |
35 | 07333066006628 | 14-5064-10 | 14-5064-10 | ImmunoCAP Allergen Rf268, Clove | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf268, Clove |
36 | 07333066006574 | 14-5060-10 | 14-5060-10 | ImmunoCAP Allergen Rf291, Cauliflower | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf291, Cauliflower |
37 | 07333066006352 | 14-5044-10 | 14-5044-10 | ImmunoCAP Allergen Rf271, Anise | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf271, Anise |
38 | 07333066006147 | 14-5026-10 | 14-5026-10 | ImmunoCAP Allergen wx209, Ambrosia sp. | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen wx209, Ambrosia sp. |
39 | 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 |
40 | 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 |
41 | 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 |
42 | 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 |
43 | 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 |
44 | 07333066005386 | 14-4950-10 | 14-4950-10 | ImmunoCAP Allergen Rw23, Yellow dock | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rw23, Yellow dock |
45 | 07333066004556 | 14-4843-01 | 14-4843-01 | ImmunoCAP Allergen f299, Sweet chestnut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f299, Sweet chestnut |
46 | 07333066004488 | 14-4836-01 | 14-4836-01 | ImmunoCAP Allergen f203, Pistachio | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f203, Pistachio |
47 | 07333066004327 | 14-4820-01 | 14-4820-01 | ImmunoCAP Allergen f207, Clam | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f207, Clam |
48 | 07333066004303 | 14-4818-01 | 14-4818-01 | ImmunoCAP Allergen f284, Turkey meat | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f284, Turkey meat |
49 | 07333066003801 | 14-4434-01 | 14-4434-01 | ImmunoCAP Allergen f254, Plaice | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f254, Plaice |
50 | 07333066003474 | 14-4364-01 | 14-4364-01 | ImmunoCAP Allergen k71, Castor bean | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen k71, Castor bean |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00847865010986 | SW4.1_V1 | 6653270E | BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
2 | 00847865002295 | SW4V3 | 6653265D | U.S. IFU, Manual & CDs, Anti-CCP IFU, SW4_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
3 | 00847865002288 | SW4_V3 | 6653270D | Anti-CCP Assay Protocol File CD, SW4_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
4 | 00847865001366 | SW4.1V1 | 6653265E | U.S Only IFU, Manual & CDs, Anti-CCP IFU, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
5 | 00847865000932 | 6633340 | 6633340 | HSV-1 & HSV-2 Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
6 | 00847865000925 | 6633330 | 6633330 | HSV-1 & HSV-2 IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
7 | 00847865000857 | 6653250 | 6653250 | Anti-CCP Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
8 | 00847865000840 | 6633240 | 6633240 | Anti-CCP Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
9 | 00847865000833 | 6633230 | 6633230 | Anti-CCP Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
10 | 00847865000826 | 6633220 | 6633220 | CD, BioPlex Anti-CCP Calibrator Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
11 | 00847865000819 | 6633200 | 6633200 | Anti-CCP Calibrator Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
12 | 00847865000529 | 6631840 | 6631840 | Vasculitis Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
13 | 00847865000512 | 6631830 | 6631830 | Vasculitis Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
14 | 00847865000437 | 6631640 | 6631640 | ToRC IgG Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
15 | 00847865000420 | 6631630 | 6631630 | ToRC IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
16 | 00847865000284 | 6631440 | 6631440 | Syphilis IgG Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
17 | 00847865000277 | 6631430 | 6631430 | Syphilis IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
18 | 00847865000222 | 6631330 | 6631330 | EBV IgM Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
19 | 00847865000215 | 6631340 | 6631340 | EBV IgM Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
20 | 00847865000154 | 6631240 | 6631240 | EBV IgG Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
21 | 00847865000147 | 6631230 | 6631230 | EBV IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
22 | 00847865000079 | 6631141 | 6631141 | ANA Screen Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
23 | 00847865000055 | 6631131 | 6631131 | ANA Screen Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
24 | 00847661005759 | 12000144 | 12000144 | Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
25 | 00847661005742 | 12000143 | 12000143 | Lyphochek Allergen sIgE Control Negative MiniPak (An assayed human based allerge Lyphochek Allergen sIgE Control Negative MiniPak (An assayed human based allergen sIgE control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
26 | 00847661005735 | 12000142 | 12000142 | Lyphochek Allergen sIgE Control Panel A (An assayed human serum allergen sIgE control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
27 | 00847661005728 | 12000141 | 12000141 | Lyphochek Allergen sIgE Control Negative (An assayed human based allergen sIgE control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
28 | 00847661005681 | 27125X | 27125X | Lyphochek Specialty Immunoassay Control MiniPak (A human serum assayed immunoass Lyphochek Specialty Immunoassay Control MiniPak (A human serum assayed immunoassay control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
29 | 00847661005674 | 27126 | 27126 | Lyphochek Specialty Immunoassay Control Level 3 (A human serum assayed immunoass Lyphochek Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
30 | 00847661005667 | 27125 | 27125 | Lyphochek Specialty Immunoassay Control Level 2 (A human serum assayed immunoass Lyphochek Specialty Immunoassay Control Level 2 (A human serum assayed immunoassay control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
31 | 00847661005650 | 27124 | 27124 | Lyphochek Specialty Immunoassay Control Level 1 (A human serum assayed immunoass Lyphochek Specialty Immunoassay Control Level 1 (A human serum assayed immunoassay control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
32 | 00847661005193 | 27110X | 27110X | Liquichek Immunoassay Premium Control Trilevel MiniPak (A processed human serum Liquichek Immunoassay Premium Control Trilevel MiniPak (A processed human serum assayed immunoassay Control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
33 | 00847661005186 | 27113 | 27113 | Liquichek Immunoassay Premium Control Level 3 (A processed human serum assayed i Liquichek Immunoassay Premium Control Level 3 (A processed human serum assayed immunoassay Control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
34 | 00847661005179 | 27112 | 27112 | Liquichek Immunoassay Premium Control Level 2 (A processed human serum assayed i Liquichek Immunoassay Premium Control Level 2 (A processed human serum assayed immunoassay Control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
35 | 00847661005162 | 27111 | 27111 | Liquichek Immunoassay Premium Control Level 1 (A processed human serum assayed i Liquichek Immunoassay Premium Control Level 1 (A processed human serum assayed immunoassay Control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
36 | 00847661005155 | 27110 | 27110 | Liquichek Immunoassay Premium Control Trilevel (A processed human serum assayed Liquichek Immunoassay Premium Control Trilevel (A processed human serum assayed immunoassay Control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
37 | 00847661005148 | 338X | 338X | Liquid Assayed Multiqual Trilevel MiniPak (A human serum assayed chemistry control.) | Multiqual | BIO-RAD LABORATORIES, INC. |
38 | 00847661005131 | 339 | 339 | Liquid Assayed Multiqual Level 3 (A human serum assayed chemistry control.) | Multiqual | BIO-RAD LABORATORIES, INC. |
39 | 00847661005124 | 338 | 338 | Liquid Assayed Multiqual Level 2 (A human serum assayed chemistry control.) | Multiqual | BIO-RAD LABORATORIES, INC. |
40 | 00847661005117 | 337 | 337 | Liquid Assayed Multiqual Level 1 (A human serum assayed chemistry control.) | Multiqual | BIO-RAD LABORATORIES, INC. |
41 | 00847661005100 | 272X | 272X | Liquichek Ethanol/Ammonia Control Trilevel MiniPak (An assayed ethanol and ammon Liquichek Ethanol/Ammonia Control Trilevel MiniPak (An assayed ethanol and ammonia control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
42 | 00847661005094 | 273 | 273 | Liquichek Ethanol/Ammonia Control Level 3 (An assayed ethanol and ammonia control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
43 | 00847661005087 | 272 | 272 | Liquichek Ethanol/Ammonia Control Level 2 (An assayed ethanol and ammonia control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
44 | 00847661005070 | 271 | 271 | Liquichek Ethanol/Ammonia Control Level 1 (An assayed ethanol and ammonia control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
45 | 00847661005063 | 302X | 302X | Liquichek Spinal Fluid Control Bilevel MiniPak (A human based assayed spinal flu Liquichek Spinal Fluid Control Bilevel MiniPak (A human based assayed spinal fluid control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
46 | 00847661005056 | 304 | 304 | Liquichek Spinal Fluid Control Level 2 (A human based assayed spinal fluid control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
47 | 00847661005049 | 303 | 303 | Liquichek Spinal Fluid Control Level 1 (A human based assayed spinal fluid control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
48 | 00847661005032 | 285X | 285X | Liquid Assayed Multiqual Premium Trilevel MiniPak (A human serum assayed chemist Liquid Assayed Multiqual Premium Trilevel MiniPak (A human serum assayed chemistry and protein control.) | Multiqual | BIO-RAD LABORATORIES, INC. |
49 | 00847661005025 | 286 | 286 | Liquid Assayed Multiqual Premium Level 3 (A human serum assayed chemistry and pr Liquid Assayed Multiqual Premium Level 3 (A human serum assayed chemistry and protein control.) | Multiqual | BIO-RAD LABORATORIES, INC. |
50 | 00847661005018 | 285 | 285 | Liquid Assayed Multiqual Premium Level 2 (A human serum assayed chemistry and pr Liquid Assayed Multiqual Premium Level 2 (A human serum assayed chemistry and protein control.) | Multiqual | BIO-RAD LABORATORIES, INC. |