| Primary Device ID | M749100420111 |
| NIH Device Record Key | 200d330b-8cd3-431b-8dec-9e33659268d3 |
| Commercial Distribution Discontinuation | 2022-01-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ANCA BP FA Test System - Ethanol Fixed Substrate - 420 Tests |
| Version Model Number | 100420-11 |
| Catalog Number | 100420-11 |
| 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 | M749100420111 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-06-06 |
| Device Publish Date | 2022-01-05 |
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