No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M7497696011 | 7696-01 | 7696-01 | RELISA® BP- Cardiolipin Screening Test - 576 wells | RELISA® Cardiolipin Antibody Screening Test | |||
2 | M7497096011 | 7096-01 | 7096-01 | RELISA® Cardiolipin Antibody Screening Test System - 96 Tests | RELISA® Cardiolipin Antibody Screening Test | |||
3 | M74900IN1101 | IN110 | IN110 | Automated microscope system for immunofluorescent determination of autoantibodies. | PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted System Fo Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | 2 | Image Navigator® |
4 | M7490302611 | 3026 (1) | 3026 (1) | nDNA FA Titratable Control - 2 x 0.5 ml | Fluorescent nDNA Test System | |||
5 | M749769609AU1 | 7696-09.Au | 7696-09.Au | RELISA® BP ENA Combination Test System - 576 Wells | RELISA® ENA Multiparameter Antibody Screening Test | |||
6 | M7497696091 | 7696-09 | 7696-09 | RELISA® BP ENA Combination Test System - 576 Wells | RELISA® ENA Multiparameter Antibody Screening Test | |||
7 | M749709609AU1 | 7096-09.Au | 7096-09.Au | RELISA® ENA Combination Test System - 96 Wells | RELISA® ENA Multiparameter Antibody Screening Test | |||
8 | M7497096091 | 7096-09 | 7096-09 | RELISA® ENA Combination Test System - 96 Wells | RELISA® ENA Multiparameter Antibody Screening Test | |||
9 | M7493075G11 | 3075G (1) | 3075G (1) | nDNA IgG Fluorescent Antibody Reagent 1 x 23 mls. | IgG Anti-nDNA Fluorescent Test System | |||
10 | M7493014101 | 3014 (10) | 3014 (10) | nDNA 14 Well Slides - 10 Slides | Fluorescent nDNA Test System | |||
11 | M7493007101 | 3007 (10) | 3007 (10) | nDNA 7 Well Slides - 10 Slides | Fluorescent nDNA Test System | |||
12 | M7493002G1 | 3002G | 3002G | nDNA IgG Fluorescent Bulk Pack - 1400 Tests | IgG Anti-nDNA Fluorescent Test System | |||
13 | M7492200RO1 | 2200-Ro | 2200-Ro | HEp-2000® Fluorescent ANA-Ro Test System - 260 Tests | Fluorescent nDNA Test System | |||
14 | M7492004141 | 2004-14 | 2004-14 | ANA Fluorescent Bulk Pack - 1400 Tests | Fluorescent nDNA Test System | |||
15 | M7490826511 | 8265.1 | 8265.1 | Custom - nDNA Fluorescent Bulk Pack - 700 Tests | Fluorescent nDNA Test System | |||
16 | M7490825011 | 8250.1 | 8250.1 | Custom - nDNA FA Test System - 140 Tests | Fluorescent nDNA Test System | |||
17 | M74903200G1 | 3200G | 3200G | IgG anti-nDNA FA Test System - 280 Tests | IgG Anti-nDNA Fluorescent Test System | |||
18 | M7490307511 | 3075 (1) | 3075 (1) | nDNA Fluorescent Antibody Reagent 1 x 23 mls. | Fluorescent nDNA Test System | |||
19 | M74903040G1 | 3040G | 3040G | IgG anti-nDNA FA Test System - 70 Tests | IgG Anti-nDNA Fluorescent Test System | |||
20 | M7490303111 | 3031 (1) | 3031 (1) | nDNA Negative Control - 1 x 5 ml | Fluorescent nDNA Test System | |||
21 | M7490302111 | 3021 (1) | 3021 (1) | nDNA Positive Control - 1 x 5 ml | Fluorescent nDNA Test System | |||
22 | M74903005G1 | 3005G | 3005G | IgG anti-nDNA Fluorescent Bulk Pack - 700 Tests | IgG Anti-nDNA Fluorescent Test System | |||
23 | M74903001G1 | 3001G | 3001G | nDNA IgG Fluorescent Bulk Pack - 1400 Tests | IgG Anti-nDNA Fluorescent Test System | |||
24 | M74903000G1 | 3000G | 3000G | IgG anti-nDNA Fluorescent Bulk Pack - 350 Tests | IgG Anti-nDNA Fluorescent Test System | |||
25 | M7490190011 | 1900 (1) | 1900 (1) | FITC Quality Control Slide | FITC Quality Control Slide ™ | |||
26 | M7490082991 | 8299 | 8299 | Custom - nDNA Fluorescent Super Bulk Pack - 4200 Tests | Fluorescent nDNA Test System | |||
27 | M7490082871 | 8287 | 8287 | Custom - IgG anti-nDNA Fluorescent Bulk Pack - 350 Tests | IgG Anti-nDNA Fluorescent Test System | |||
28 | M7490030051 | 3005 | 3005 | nDNA Fluorescent Bulk Pack - 700 Tests | Fluorescent nDNA Test System | |||
29 | M7490082841 | 8284 | 8284 | Custom - DNA IgG Fluorescent Bulk Pack - 1400 Tests | IgG Anti-nDNA Fluorescent Test System | |||
30 | M7490082681 | 8268 | 8268 | Custom - ANA Sample Diluent Bulk Pack - 100 x 100mls | Fluorescent nDNA Test System | |||
31 | M7490082271 | 8227 | 8227 | Custom- nDNA Fluorescent Bulk Pack - 700 Tests | Fluorescent nDNA Test System | |||
32 | M7490081971 | 8197 | 8197 | Custom - nDNA IgG Fluorescent Bulk Pack - 1400 Tests | IgG Anti-nDNA Fluorescent Test System | |||
33 | M7490081961 | 8196 | 8196 | Custom - nDNA IgG Fluorescent Bulk Pack - 700 Tests | IgG Anti-nDNA Fluorescent Test System | |||
34 | M7490081221 | 8122 | 8122 | Custom - nDNA FA BP - 4200 wells | Fluorescent nDNA Test System | |||
35 | M7490032001 | 3200 | 3200 | nDNA FA Test System - 280 Tests | Fluorescent nDNA Test System | |||
36 | M7490030401 | 3040 | 3040 | nDNA FA Test System - 70 tests. | Fluorescent nDNA Test System | |||
37 | M7490030011 | 3001 | 3001 | nDNA Fluorescent Bulk Pack - 1400 Tests | Fluorescent nDNA Test System | |||
38 | M7490030001 | 3000 | 3000 | nDNA Fluorescent Bulk Pack - 350 Tests | Fluorescent nDNA Test System | |||
39 | M7498400RO1 | 8400-Ro | 8400-Ro | Custom: HEp-2000® FA ANA-Ro Super BP - 5400 Tests | HEp-2000® Fluorescent ANA-Ro Test System | |||
40 | M7498300RO1 | 8300-Ro | 8300-Ro | Custom - HEp-2000® FA ANA-Ro Super BP - 6300 Tests | HEp-2000® Fluorescent ANA-Ro Test System | |||
41 | M7498296RO1 | 8296-Ro | 8296-Ro | Custom - HEp-2000® FA ANA-Ro Super BP - 6300 Tests | HEp-2000® Fluorescent ANA-Ro Test System | |||
42 | M7498295RO1 | 8295-Ro | 8295-Ro | Custom: HEp-2000® FA ANA-Ro Super BP - 6300 Tests | HEp-2000® Fluorescent ANA-Ro Test System | |||
43 | M7498262RO1 | 8262-Ro | 8262-Ro | Custom - HEp-2000® FA ANA-Ro BP - 6300 wells | HEp-2000® Fluorescent ANA-Ro Test System | |||
44 | M7498248RO1 | 8248-Ro | 8248-Ro | Custom: HEp-2000® FA ANA-Ro Super BP - 4200 Tests | HEp-2000® Fluorescent ANA-Ro Test System | |||
45 | M7498246RO1 | 8246-Ro | 8246-Ro | Custom- HEp-2000® IgG Fluorescent w/cs ANA-Ro BP - 700 Tests | HEp-2000® Fluorescent ANA-Ro Test System | |||
46 | M7498224RO1 | 8224-Ro | 8224-Ro | Custom - HEp-2000® FA ANA-Ro BP - 1300 Tests | HEp-2000® Fluorescent ANA-Ro Test System | |||
47 | M74982071RO1 | 8207.1-Ro | 8207.1-Ro | Custom - HEp-2000® FA ANA-Ro BP - 1800 Tests | HEp-2000® Fluorescent ANA-Ro Test System | |||
48 | M7498153RO1 | 8153-Ro | 8153-Ro | Custom - HEp-2000® FA ANA-Ro BP - 1400 Tests | HEp-2000® Fluorescent ANA-Ro Test System | |||
49 | M74981491RO1 | 8149.1-Ro | 8149.1-Ro | Custom - HEp-2000® FA ANA-Ro BP - 5400 Wells | HEp-2000® Fluorescent ANA-Ro Test System | |||
50 | M7498127RO1 | 8127-Ro | 8127-Ro | Custom - HEp-2000® FA ANA-Ro Super BP - 4200 Tests | HEp-2000® Fluorescent ANA-Ro Test System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 42601861205090 | AUTOMATED IFA SYSTEM | IOS-1000 | Automated system for immunofluorescence processing with an integrated fluorescen Automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. | HELIOS | AESKU.SYSTEMS GMBH & CO. KG |
2 | M74900IN2201 | IN220 | IN220 | Automated microscope system for immunofluorescent determination of autoantibodies. | Image Navigator® | IMMUNO CONCEPTS INC |
3 | M74900IN1101 | IN110 | IN110 | Automated microscope system for immunofluorescent determination of autoantibodies. | Image Navigator® | IMMUNO CONCEPTS INC |
4 | 08426951056538 | 708215 | 1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide2. 1 x 15mL FITC Anti- 1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide2. 1 x 15mL FITC Anti-Human IgG Conjugate with DAPI3. 1 x 0.5mL dsDNA Positive4. 1 x 0.5mL IFA System Negative Control5. 2 x 25mL PBS II Concentrate (40x)6. 1 x 7mL Mounting Medium7. 1 x 20 Coverslips | NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit | INOVA DIAGNOSTICS, INC. | |
5 | 08426950643708 | ALDR1000 | The NOVA View AUTOLoader is an optional hardware accessory that performs the aut The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction. | NOVA View® AUTOLoader | INOVA DIAGNOSTICS, INC. | |
6 | 08426950621843 | 704320 | 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® DAPI ANA Kit | INOVA DIAGNOSTICS, INC. | |
7 | 08426950621614 | NV2000 | NOVA View® Automated Fluorescent Microscope is an automated system consisting of NOVA View® Automated Fluorescent Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. Optional AutoLoader available as an accessory. | NOVA View® | INOVA DIAGNOSTICS, INC. | |
8 | 08059304340109 | Zeus dIFine | Zeus dIFine | VISIA LAB SRL | ||
9 | 04260186125096 | AUTOMATED IFA SYSTEM | IOS-1000 | Automated system for immunofluorescence processing with an integral fluorescence Automated system for immunofluorescence processing with an integral fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. | HELIOS | AESKU.SYSTEMS GMBH & CO. KG |
10 | 04049016135975 | FC 1201-18010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
11 | 04049016135968 | FC 1201-18010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
12 | 04049016135951 | FC 1201-18010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
13 | 04049016135944 | FC 1201-18010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
14 | 04049016135937 | FC 1201-18010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
15 | 04049016135920 | FC 1201-12010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
16 | 04049016135913 | FC 1201-2450-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
17 | 04049016135906 | FC 1201-1050-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
18 | 04049016135890 | FC 1201-12010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
19 | 04049016135883 | FC 1201-2450-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
20 | 04049016135876 | FC 1201-2450-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
21 | 04049016135869 | FC 1201-12010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
22 | 04049016135852 | FC 1201-1050-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
23 | 04049016135845 | FC 1201-12010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
24 | 04049016135838 | FC 1201-2450-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
25 | 04049016135821 | FC 1201-1050-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
26 | 04049016135814 | FC 1201-2450-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
27 | 04049016135807 | FC 1201-1050-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
28 | 04049016135739 | FC 1522-2450-1 | IFA 40: HEp-20-10 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
29 | 04049016135722 | FC 1522-12010-1 | IFA 40: HEp-20-10 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
30 | 04049016121497 | FC 1201-12010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
31 | 04049016119920 | FC 1201-1050-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
32 | 04049016108962 | FC 1201-2010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
33 | 04049016108955 | FC 1201-2005-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
34 | 04049016108948 | FC 1201-1010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
35 | 04049016108931 | FC 1201-1005-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
36 | 04049016108863 | FC 1201-2010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
37 | 04049016108856 | FC 1201-2005-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
38 | 04049016108849 | FC 1201-1010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
39 | 04049016108832 | FC 1201-1005-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
40 | 04049016108764 | FC 1201-2010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
41 | 04049016108757 | FC 1201-2005-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
42 | 04049016108740 | FC 1201-1010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
43 | 04049016108733 | FC 1201-1005-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
44 | 04049016108665 | FC 1201-2010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
45 | 04049016108658 | FC 1201-2005-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
46 | 04049016108641 | FC 1201-1010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
47 | 04049016108634 | FC 1201-1005-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
48 | 04049016108566 | FC 1201-2010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
49 | 04049016108559 | FC 1201-2005-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
50 | 04049016108542 | FC 1201-1010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG |