| Primary Device ID | M7490303111 |
| NIH Device Record Key | 3c6434c0-83ea-4429-84ad-7c8ab753c5b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fluorescent nDNA Test System |
| Version Model Number | 3031 (1) |
| Catalog Number | 3031 (1) |
| 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 | M7490303111 [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 | 2019-11-12 |
| Device Publish Date | 2016-09-24 |
| M7493014101 | nDNA 14 Well Slides - 10 Slides |
| M7493007101 | nDNA 7 Well Slides - 10 Slides |
| M7490030051 | nDNA Fluorescent Bulk Pack - 700 Tests |
| M7490307511 | nDNA Fluorescent Antibody Reagent 1 x 23 mls. |
| M7490032001 | nDNA FA Test System - 280 Tests |
| M7490826511 | Custom - nDNA Fluorescent Bulk Pack - 700 Tests |
| M7490303111 | nDNA Negative Control - 1 x 5 ml |
| M7490081221 | Custom - nDNA FA BP - 4200 wells |
| M7490030001 | nDNA Fluorescent Bulk Pack - 350 Tests |
| M7490082271 | Custom- nDNA Fluorescent Bulk Pack - 700 Tests |
| M7490030401 | nDNA FA Test System - 70 tests. |
| M7492200RO1 | HEp-2000® Fluorescent ANA-Ro Test System - 260 Tests |
| M7492004141 | ANA Fluorescent Bulk Pack - 1400 Tests |
| M7490825011 | Custom - nDNA FA Test System - 140 Tests |
| M7490302611 | nDNA FA Titratable Control - 2 x 0.5 ml |
| M7490302111 | nDNA Positive Control - 1 x 5 ml |
| M7490082991 | Custom - nDNA Fluorescent Super Bulk Pack - 4200 Tests |
| M7490082681 | Custom - ANA Sample Diluent Bulk Pack - 100 x 100mls |
| M7490030011 | nDNA Fluorescent Bulk Pack - 1400 Tests |