| Primary Device ID | M7492000141 |
| NIH Device Record Key | a36cbf39-c6db-4bc7-9109-3035bc48406b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fluorescent ANA Test System |
| Version Model Number | 2000-14 |
| Catalog Number | 2000-14 |
| Company DUNS | 038271904 |
| Company Name | IMMUNO CONCEPTS INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7492000141 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-14 |
| Device Publish Date | 2016-09-24 |
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| M7490812811 | Custom - ANA FA BP - 1800 wells |
| M7490802111 | Custom - ANA FA Super Bulk Pack - 5400 Tests |
| M7490110541 | Universal Counterstain (0.5% Evan's Blue) - 4 x 5 ml |
| M7490082601 | Custom - HEp-2 FA ANA w/cs Super Bulk Pack - 5400 Tests |
| M7490080191 | Custom - ANA FA Slides Only - 100 x 13 Well |
| M7492007101 | ANA 7 Well HEp-2 Slides - 10 Slides |
| M7490020401 | ANA Fluorescent Test System - 70 Tests |
| M7492280CS1 | HEp-2 FA w/cs ANA Test System - 280 Tests |
| M7492140CS1 | HEp-2 FA w/cs ANA Test System - 140 Tests |
| M7490817211 | Custom - ANA FA BP - 7000 Tests |
| M7490207511 | ANA IgG (H & L Chain) Fluorescent Antibody Reagent - 1 x 23 mls. |
| M74900M1211 | OEM ANA HEp-2 - 1 x 12 well slide |
| M7490082761 | Custom - ANA Sample Diluent Bulk Pack - 100 x 100mls |
| M7490010001 | Serum Diluent 4 x 500ml |
| M7492200141 | ANA Fluorescent Test System - 280 Tests |
| M7492004CS141 | ANA Fluorescent w/cs Bulk Pack - 1400 Tests |
| M7490083171 | Custom - ANA Fluorescent w/cs Bulk Pack - 1800 Tests |
| M7490080601 | Custom - ANA FA Slides Only - 650 x 13 Well |
| M7490817221 | Custom - ANA FA BP - 7000 Tests |
| M7490081451 | Custom - ANA FA Super Bulk Pack - 4200 Wells |
| M7490080671 | Custom - ANA FA BP - 9000 Tests |
| M7490022001 | ANA Fluorescent Test System - 260 Tests |
| M7490020041 | ANA Fluorescent Bulk Pack - 1300 Tests |
| M7490020031 | ANA Fluorescent Bulk Pack - 1300 Tests |
| M7490020001 | ANA Fluorescent Bulk Pack - 1300 Tests |
| M7492014101 | ANA 14 Well HEp-2 Slides - 10 Slides |
| M7492013201 | ANA 13 Well HEp-2 Slides - 20 Slides |
| M7492000141 | ANA Fluorescent Bulk Pack -1400 Tests |
| M7490812111 | Custom - ANA FA Super Bulk Pack - 4200 wells |
| M7490083111 | Custom - ANA Fluorescent w/cs BP - 7000 Tests |
| M7490082611 | Custom - HEp-2 FA ANA w/cs Super Bulk Pack - 5400 Tests |
| M7490021001 | ANA Fluorescent Test System - 130 Tests |
| M7490020051 | ANA Fluorescent Bulk Pack - 650 Tests |
| M7490005001 | Serum Diluent 2 x 500ml |
| M7490001001 | Serum Diluent 2 x 100ml |
| M7490831121 | Custom - ANA Fluorescent w/cs BP - 7000 Tests |
| M7492040CS1 | ANA Fluorescent w/cs Test System - 70 Tests |
| M7490083231 | ANA Fluorescent w/cs Bulk Pack - 1400 Tests |