No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00847865000758 | 6632440 | 6632440 | MMRV IgG Control Lot Data | OPL,LJY,LFY,LJB | Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zost Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Enzyme linked immunoabsorbent assay, rubeola IgG | 1 | BioPlex 2200 |
2 | 00847865000437 | 6631640 | 6631640 | ToRC IgG Control Lot Data | JJY | Multi-analyte controls, all kinds (assayed) | 1 | BioPlex 2200 |
3 | 00847865013017 | SW4.1V1 | 6652365A | Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
4 | 00847865013000 | SW4.1V1 | 6652365A | Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
5 | 00847865012997 | SW4.1_1 | 6652165B | Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only | MID,MSV | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | BioPlex 2200 |
6 | 00847865012980 | SW4.1V1 | 6652065B | Manual & CDs, APLS IgM IFU, SW4.1_v1 | MID,MSV | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | BioPlex 2200 |
7 | 00847865012973 | SW4.1V1 | 6651975B | APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
8 | 00847865012966 | SW4.1V1 | 6651965B | Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
9 | 00847865012614 | SW4.1_V1 | 6651260F | Manual & CDs, EBV IgG IFU, SW4.1v1 | LSE | EPSTEIN-BARR VIRUS, OTHER | 1 | BioPlex 2200 |
10 | 00847865012607 | SW4.1_V1 | 6651270D | EBV IgG Assay Protocol File CD, SW4.1_v1, US | LSE | EPSTEIN-BARR VIRUS, OTHER | 1 | BioPlex 2200 |
11 | 00847865012577 | SW4.1_V1 | 6653860D | Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only | LFX,LKQ,LFZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
12 | 00847865012522 | SW4_1 | 6651965A | Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
13 | 00847865012515 | SW4_1 | 6652065A | Manual & CDs, APLS IgM IFU, SW4_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
14 | 00847865012508 | SW4_1 | 6651975A | APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1 | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
15 | 00847865011655 | 6653750 | 6653750 | 25-OH Vitamin D Reagent Pack | MRG | SYSTEM, TEST, VITAMIN D | 2 | BioPlex 2200 |
16 | 00847865011648 | 6633740 | 6633740 | 25-OH Vitamin D Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
17 | 00847865011631 | 6633730 | 6633730 | 25-OH Vitamin D Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
18 | 00847865011624 | 6633720 | 6633720 | 25-OH Vitamin D Lot Data | JIT | CALIBRATOR, SECONDARY | 2 | BioPlex 2200 |
19 | 00847865011617 | 6633700 | 6633700 | 25-OH Vitamin D Calibrator Set | JIT | CALIBRATOR, SECONDARY | 2 | BioPlex 2200 |
20 | 00847865011358 | SW4V2 | 6651360F | Manual & CDs, EBV IgM IFU, SW4_v2 | LJN,KTN | ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 1 | BioPlex 2200 |
21 | 00847865011341 | 6651360G | 6651360G | Manual & CDs, EBV IgM IFU, SW4.1_v1 | LJN,KTN | ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 1 | BioPlex 2200 |
22 | 00847865011129 | SW4_1 | 6652360A | Manual & CDs, Celiac IgA and IgG IFU, SW4_v1 | MST,MVM | Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) | 2 | BioPlex 2200 |
23 | 00847865011105 | 6600306 | 6600306 | BioPlex® 2200 Manual Reagent Pack Piercer | MZF | Test, Hiv Detection | 2 | BioPlex® 2200 |
24 | 00847865011082 | SW4.1V1 | 6651860H | Manual & CDs, Vasculitis IFU, SW4.1_v1 | MOB,MVJ | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) | 2 | BioPlex 2200 |
25 | 00847865011075 | SW4.1_1 | 6651665E | U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1 | OMI | Multiplex flow immunoassay, t.Gondii, rubella and cmv. | 2 | BioPlex 2200 |
26 | 00847865011006 | SW4.1_V1 | 6653870D | Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 | LFX,LKQ,LFZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
27 | 00847865010993 | SW4.1_V2 | 6653370E | HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2 | MYF,MXJ | Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1 | 2 | BioPlex 2200 |
28 | 00847865010986 | SW4.1_V1 | 6653270E | BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1 | JIX,NHX,JJY | CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP),Multi-analyte controls, all kinds (assayed) | 1 | BioPlex 2200 |
29 | 00847865010979 | SW4.1_V1 | 6652470D | MMRV IgG Assay Protocol File CD, SW4.1_v1 | LJY,LFY,OPL,LJB | ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT A ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,Enzyme linked immunoabsorbent assay, rubeola IgG | 1 | BioPlex 2200 |
30 | 00847865010962 | SW4.1v1 | 6652270B | Celiac IgG Assay Protocol File CD, SW4.1_v1 | MST,MVM | Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) | 2 | BioPlex 2200 |
31 | 00847865010955 | SW4.1 V1 | 6651870E | Vasculitis Assay Protocol File CD, SW4.1_v1 | MOB,MVJ | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) | 2 | BioPlex 2200 |
32 | 00847865010948 | SW4.1_V1 | 6651670H | ToRC IgG Assay Protocol File CD, SW4.1_v1 | OMI | Multiplex flow immunoassay, t.Gondii, rubella and cmv. | 2 | BioPlex 2200 |
33 | 00847865010924 | SW4.1_v1 | 6651470E | Syphilis IgG Assay Protocol File CD, SW4.1_v1 | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | BioPlex 2200 |
34 | 00847865010917 | 6632220 | 6632220 | Celiac IgG Calibrator Lot Data | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
35 | 00847865010900 | 6632320 | 6632320 | Celiac IgA Calibrator Lot Data | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
36 | 00847865010894 | 6632240 | 6632240 | Celiac IgG Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
37 | 00847865010887 | 6632340 | 6632340 | Celiac IgA Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
38 | 00847865010863 | 6652250 | 6652250 | Celiac IgG Reagent Pack | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
39 | 00847865010856 | 6652350 | 6652350 | Celiac IgA Reagent Pack | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
40 | 00847865010627 | 6632230 | 6632230 | Celiac IgG Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
41 | 00847865010610 | 6632330 | 6632330 | Celiac IgA Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
42 | 00847865010603 | 6632200 | 6632200 | Celiac IgG Calibrator Set, | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
43 | 00847865010597 | 6632300 | 6632300 | Celiac IgA Calibrator Set | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
44 | 00847865010580 | SW4_v1 | 6652370A | Celiac IgA Assay Protocol File CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
45 | 00847865010573 | SW4_v1 | 6652270A | Celiac IgG Assay Protocol file CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
46 | 00847865006682 | SW4.1_V1 | 6651460F | Manual & CDs, Syphilis IgG IFU, SW4.1_v1 | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | BioPlex 2200 |
47 | 00847865004725 | SW4_V2 | 6653360E | Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4_v2 | MXJ,MYF | Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 | 2 | BioPlex 2200 |
48 | 00847865003186 | SW4_ V3 | 6653870C | Rubella & CMV Assay Protocol File CD, SW4_v3 | LFZ,LKQ,LFX | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALO ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA | 2 | BioPlex 2200 |
49 | 00847865003179 | SW4_V3 | 6653860C | Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only | LKQ,LFX,LFZ | ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBE ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
50 | 00847865002998 | SW4_1 | 6652165A | Manual & CDs, APLS IgA IFU, SW4_v1, US Only | MID,MSV | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | BioPlex 2200 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B350GSD0113000 | GSD01-1300 | Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit | Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
2 | B3507202800 | 720-280 | 720-280 | ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the diagnosis of autoimmune disease. | Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
3 | B24235E6PHUE010 | 35-E6PHU-E01 | 35-E6PHU-E01 | The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquan The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings. | ENA-6Pro ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
4 | B24235ANAHUE010 | 35-ANAHU-E01 | 35-ANAHU-E01 | The ANA-8Pro ELISA is a solid phase enzyme immunoassay for the separate qualitat The ANA-8Pro ELISA is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings. | ANA-8Pro ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
5 | 10080196000616 | 60787 | 60787 | COVER,CASSETTE,X-RAY,NS | Medline | MEDLINE INDUSTRIES, INC. |
6 | 08426950793182 | 701333 | 1 QUANTA Flash HMGCR Reagent Cartridge.1 Resuspension Buffer.1 Transfer pipette. | QUANTA Flash® HMGCR Reagents | INOVA DIAGNOSTICS, INC. | |
7 | 08426950724476 | 701328 | 1 . QUANTA Flash Scl-70 Reagent Cartridge1. Resuspension buffer 2 1. Transfer pipette | QUANTA Flash® Scl-70 Reagents | INOVA DIAGNOSTICS, INC. | |
8 | 08426950627821 | 701255 | 1. 1 QUANTA Flash ENA7 Reagent Cartridge2. 1 Resuspension buffer3. 1 Transfer pipet" | QUANTA Flash® ENA7 Reagents | INOVA DIAGNOSTICS, INC. | |
9 | 08426950596455 | 708495 | 1. 8 prepunched NOVA Gel titering “T” plates2. 2 0.4mL Jo-1 antigen, lyophilized 1. 8 prepunched NOVA Gel titering “T” plates2. 2 0.4mL Jo-1 antigen, lyophilized3. 1 1.4mL Jo-1 Control | NOVA Gel® Jo-1 “T” Extractable Nuclear Autoantibody Reagents | INOVA DIAGNOSTICS, INC. | |
10 | 08426950596387 | 708155 | 1. 20x 4-well ANA Plus Substrate Slides2. 1x 15mL FITC Anti-Human IgG Conjugate3 1. 20x 4-well ANA Plus Substrate Slides2. 1x 15mL FITC Anti-Human IgG Conjugate3. 1x 0.5mL ANA Homogeneous Pattern4. 1x 0.5mL IFA System Negative Control5. 2x 25mL PBS Concentrate (40x)6. 1x 7mL Mounting Medium7. 1x 20 Coverslips | NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach | INOVA DIAGNOSTICS, INC. | |
11 | 08426950595878 | 701148 | 1 QUANTA Flash Ro60 Reagent Cartridge1 Resuspension buffer 1 Transfer pipette | QUANTA Flash® Ro60 Reagents | INOVA DIAGNOSTICS, INC. | |
12 | 08426950595786 | 701153 | 1. 1 QUANTA Flash SS-B Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipette | QUANTA Flash® SS-B Reagents | INOVA DIAGNOSTICS, INC. | |
13 | 08426950595632 | 701198 | 1. 1 QUANTA Flash Centromere Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet | QUANTA Flash® Centromere Reagents | INOVA DIAGNOSTICS, INC. | |
14 | 08426950595410 | 701163 | 1. 1 QUANTA Flash Jo-1 Reagent Cartridge | QUANTA Flash® Jo-1 Reagents | INOVA DIAGNOSTICS, INC. | |
15 | 08426950595311 | 708475 | 1. 8 Prepunched NOVA Gel titering “T” plates2. 2 0.4mL Scl-70 antigen, lyophiliz 1. 8 Prepunched NOVA Gel titering “T” plates2. 2 0.4mL Scl-70 antigen, lyophilized3. 1 1.4mL Scl-70 Control | NOVA Gel® Scl-70 “T” Extractable Nuclear Autoantibody Reagents | INOVA DIAGNOSTICS, INC. | |
16 | 08426950595151 | 701118 | 1. 1 QUANTA Flash RNP Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet | QUANTA Flash® RNP Reagents | INOVA DIAGNOSTICS, INC. | |
17 | 08426950594857 | 708180 | 1. 1x 0.5mL ANA Homogeneous/dsDNA pattern 2. 1x 0.5 ANA Speckled Pattern 3. 1x 0 1. 1x 0.5mL ANA Homogeneous/dsDNA pattern 2. 1x 0.5 ANA Speckled Pattern 3. 1x 0.5 ANA Nucleolar Pattern 4. 1x 0.5 ANA Centromere pattern 5. 1x 0.5 ANA Scl-70 pattern | NOVA Lite® Auto AB Panel | INOVA DIAGNOSTICS, INC. | |
18 | 08426950594505 | 708470 | 1. 8 prepunched NOVA Gel screening ""S"" plates2. 2 0.4mL Scl-70 antigen, lyophi 1. 8 prepunched NOVA Gel screening ""S"" plates2. 2 0.4mL Scl-70 antigen, lyophilized3. 1 1.4mL Scl-70 Control | NOVA Gel® Scl-70 “S” Extractable Nuclear Autoantibody Reagents | INOVA DIAGNOSTICS, INC. | |
19 | 08426950594048 | 708455 | 1. 8 prepunched NOVA Gel titering “T” plates2. 1. 8 prepunched NOVA Gel titering “T” plates2. 2 0.4mL SS-A/SS-B antigen, lyophilized3. 1 0.7mL SS-B Control4. 1 0.7mL SS-A Control | NOVA Gel® SS-A/SS-B “T” Extractable Nuclear AutoantibodyReagents | INOVA DIAGNOSTICS, INC. | |
20 | 08426950593966 | 708415 | 1. 8 prepunched NOVA Gel titering ""T"" plates2. 2 0.4mL Sm/RNP antigen, lyophil 1. 8 prepunched NOVA Gel titering ""T"" plates2. 2 0.4mL Sm/RNP antigen, lyophilized3. 1 0.7mL Sm Control4. 1 0.7mL RNP Control | NOVA Gel® Sm/RNP “T” Extractable Autoantibody Reagents | INOVA DIAGNOSTICS, INC. | |
21 | 08426950593812 | 708450 | 1. 8 prepunched NOVA Gel screening ""S"" plates2. 2 0.4mL SS-A/SS-B antigen, lyo 1. 8 prepunched NOVA Gel screening ""S"" plates2. 2 0.4mL SS-A/SS-B antigen, lyophilized3. 1 0.7mL SS-B Control4. 1 0.7mL SS-A Control | NOVA Gel® SS-A/SS-B “S” Extractable Nuclear Autoantibody Reagents | INOVA DIAGNOSTICS, INC. | |
22 | 08426950593782 | 708410 | 1. 8 prepunched NOVA Gel screening ""S"" plates2. 2 0.4mL Sm/RNP antigen, lyoph 1. 8 prepunched NOVA Gel screening ""S"" plates2. 2 0.4mL Sm/RNP antigen, lyophilized3. 1 0.7mL Sm Control4. 1 0.7mL RNP Control | NOVA Gel®Sm/RNP “S” Extractable Nuclear Autoantibody Reagents | INOVA DIAGNOSTICS, INC. | |
23 | 08426950593744 | 708525 | 1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ssDNA ELISA Low Positive4. 1 x1.2mL prediluted ssDNA ELISA High Positive5. 1 x50mL HRP Sample Diluent6. 1 x25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid" | QUANTA Lite® ssDNA ELISA | INOVA DIAGNOSTICS, INC. | |
24 | 08426950593577 | 708102 | 1. 20x ANA Hep- 2 -QR Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1 1. 20x ANA Hep- 2 -QR Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1x 15mL FITC IgG Conjugate with DAPI 4. 1x 7mL Mounting Medium5. 2x 25mL PBS II Concentrate (40x)6 .1x Coverlips, 20 each7. 1x 0.5mL ANA Titratable Pattern | NOVA Lite® ANA Kit with DAPI | INOVA DIAGNOSTICS, INC. | |
25 | 08426950593539 | 708150 | 1. 20x 8-well ANA Plus Substrate Slides2. 1x 15mL FITC Anti-Human IgG Conjugate3 1. 20x 8-well ANA Plus Substrate Slides2. 1x 15mL FITC Anti-Human IgG Conjugate3. 1x 0.5mL ANA Homogeneous Pattern4. 1x 0.5mL IFA System Negative Control5. 2x 25mL PBS Concentrate (40x)6. 1x 7mL Mounting Medium7. 1x 20 Coverslips | NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach | INOVA DIAGNOSTICS, INC. | |
26 | 08426950593478 | 704615 | 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. C1q Coated Wells: 12 breakapart 8 well strips coated with human C1q. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.5. C1q CIC Calibrators: 5 bottles, each containing 1.2mL of diluted aggregated human IgG, with the following concentrations of immune complex: 100, 33.3, 11.1, 3.7, 1.23 µg Eq/mL. Ready to use.6. C1q CIC Positive Control: 1 bottle containing 1.2mL of diluted aggregated human IgG. The expected value is given on the QC certificate. Ready to use.7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use.8. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 9. HRP C1q CIC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.10.TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use. | QUANTA Lite® HA dsDNA ELISA | INOVA DIAGNOSTICS, INC. | |
27 | 08426950593461 | 708101 | 1. 5 x 12-well HEp-2 Substrate Slides2. 1 x 4mL FITC Anti-Human IgG Conjugate3. 1. 5 x 12-well HEp-2 Substrate Slides2. 1 x 4mL FITC Anti-Human IgG Conjugate3. 1 x 0.5 mL ANA Titratable Endpoint Pattern Control4. 1 x 0.5mL IFA System Negative Control5. 1 x 25mL PBS II Concentrate (40x)6. 1 x 7mL Mounting Medium7. 1 x 20 Coverslips | NOVA Lite® HEp-2 ANA Kit | INOVA DIAGNOSTICS, INC. | |
28 | 08426950566373 | 701258 | 1. 1 QUANTA Flash ENA7 Reagent Cartridge2. 1 Resuspension buffer3. 1 Transfer pipet" | QUANTA Flash® ENA7 Reagents | INOVA DIAGNOSTICS, INC. | |
29 | 08426950544227 | 708610 | 1. 1x ENA 5 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predi 1. 1x ENA 5 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ENA 5 ELISA Low Positive4. 1x 1.2mL prediluted ENA 5 ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ENA 5 ELISA | INOVA DIAGNOSTICS, INC. | |
30 | 08426950544128 | 708770 | (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with ho (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted Centromere ELISA Low Positive4.1x 1.2mL prediluted Centromere ELISA High Positive5.1x 50mL HRP Sample Diluent6.1 x25mL HRP Wash Concentrate, 40x concentrate7.1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8.1x 10mL TMB Chromogen9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Centromere ELISA | INOVA DIAGNOSTICS, INC. | |
31 | 08426950544111 | 704650 | 1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating t 1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. dsDNA SC Coated Wells: 12 breakapart 8 well strips coated with calf thymus dsDNA antigen. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.5. dsDNA SC Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-dsDNA autoantibody: 1000, 333, 111, 37, 12.3 IU/mL. Ready to use.6. dsDNA SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use.8. HRP Wash Concentrate (40X): 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.9.dsDNA SC Single Stranded Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.10. HRP dsDNA SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.11. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.12. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use. | QUANTA Lite® dsDNA SC ELISA | INOVA DIAGNOSTICS, INC. | |
32 | 08426950514015 | 708585 | 1. 1x Jo-1 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predil 1. 1x Jo-1 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Jo-1 ELISA Low Positive4. 1x 1.2mL prediluted Jo-1 ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Jo-1 ELISA | INOVA DIAGNOSTICS, INC. | |
33 | 08426950506355 | 708710 | 1. 1x Chromatin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL p 1. 1x Chromatin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Chromatin ELISA Low Positive4. 1x 1.2mL prediluted Chromatin ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Chromatin ELISA | INOVA DIAGNOSTICS, INC. | |
34 | 08426950506348 | 708600 | 1. 1x Ribosome P ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1. 1x Ribosome P ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Ribosome P ELISA Low Positive4. 1x 1.2mL prediluted Ribosome P ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Ribosome P ELISA | INOVA DIAGNOSTICS, INC. | |
35 | 08426950506331 | 708520 | 1. 1x Histone ELISA microwell plate (12-1 x 8 wells), with holder2. 1 x1.2mL pr 1. 1x Histone ELISA microwell plate (12-1 x 8 wells), with holder2. 1 x1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Histone ELISA Low Positive4. 1x 1.2mL prediluted Histone ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Histone ELISA | INOVA DIAGNOSTICS, INC. | |
36 | 08426950456193 | 708100 | 1. 20x Hep- 2 ANA Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1x 1. 20x Hep- 2 ANA Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1x 15mL FITC IgG Conjugate 4. 1x 7mL Mounting Medium5. 2x 25mL PBS II Concentrate (40x)6 .1x Coverlips, 20 each7. 1x 0.5mL ANA Titratable Pattern | NOVA Lite® HEp-2 ANA Kit | INOVA DIAGNOSTICS, INC. | |
37 | 08426950456186 | 708580 | 1. 1x Scl-70 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x Scl-70 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Scl-70 ELISA Low Positive4. 1x 1.2mL prediluted Scl-70 ELISA High Positive5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Scl-70 ELISA | INOVA DIAGNOSTICS, INC. | |
38 | 08426950456179 | 708575 | 1. 1x SS-B ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predil 1. 1x SS-B ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted SS-B ELISA Low Positive4. 1x 1.2mL prediluted SS-B ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® SS-B ELISA | INOVA DIAGNOSTICS, INC. | |
39 | 08426950456162 | 708570 | 1. 1x SS-A ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predil 1. 1x SS-A ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted SS-A ELISA Low Positive4. 1x 1.2mL prediluted SS-A ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® SS-A ELISA | INOVA DIAGNOSTICS, INC. | |
40 | 08426950456155 | 708565 | 1. 1 x RNP ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predi 1. 1 x RNP ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted RNP ELISA Low Positive4. 1x 1.2mL prediluted RNP ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1 x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® RNP ELISA | INOVA DIAGNOSTICS, INC. | |
41 | 08426950456148 | 708560 | 1. 1 x Sm ELISA microwell plate (12-1 x 8 wells), with holder2. 1 x 1.2mL predi 1. 1 x Sm ELISA microwell plate (12-1 x 8 wells), with holder2. 1 x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Sm ELISA Low Positive4. 1x 1.2mL prediluted Sm ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1 x10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Sm ELISA | INOVA DIAGNOSTICS, INC. | |
42 | 08426950455127 | 708615 | 1. 1x ENA 6 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predi 1. 1x ENA 6 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ENA 6 ELISA Low Positive4. 1x 1.2mL prediluted ENA 6 ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ENA 6 ELISA | INOVA DIAGNOSTICS, INC. | |
43 | 08426950454502 | 708510 | 1. 1x dsDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x1.2mL predi 1. 1x dsDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted dsDNA ELISA Positive4. 1x 1.2mL prediluted dsDNA ELISA Calibrator5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® dsDNA ELISA | INOVA DIAGNOSTICS, INC. | |
44 | 08426950454496 | 708555 | 1. 1x ENA 4 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predi 1. 1x ENA 4 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ENA 4 ELISA Low Positive4. 1x 1.2mL prediluted ENA 4 ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ENA 4 ELISA | INOVA DIAGNOSTICS, INC. | |
45 | 08426950454458 | 708725 | 1. 1x TPO ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predilu 1. 1x TPO ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted TPO ELISA Control4. 1x 1.2mL prediluted TPO ELISA Calibrator A5. 1x 1.2mL prediluted TPO ELISA Calibrator B6. 1x 1.2mL prediluted TPO ELISA Calibrator C7. 1x 1.2mL prediluted TPO ELISA Calibrator D8. 1x 1.2mL prediluted TPO ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® TPO ELISA | INOVA DIAGNOSTICS, INC. | |
46 | 08426950454373 | 708750 | 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predilu 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ANA ELISA Low Positive4. 1x 1.2mL prediluted ANA ELISA High Positive5. 1x 50mL ANA Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HS HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ANA ELISA | INOVA DIAGNOSTICS, INC. | |
47 | 07340058410509 | FAID200 | FAID200 | DIASTAT ENA Profile | EURO-DIAGNOSTICA AB | |
48 | 07340058410493 | FSWS200 | FSWS200 | DIASTAT ENA Single Well Screen | EURO-DIAGNOSTICA AB | |
49 | 07340058410486 | FANA200 | FANA200 | DIASTAT ANA | EURO-DIAGNOSTICA AB | |
50 | 07340058410462 | FSCL200 | FSCL200 | DIASTAT anti-SCL-70 | EURO-DIAGNOSTICA AB |