| Primary Device ID | 00817238010417 |
| NIH Device Record Key | bd28d577-645e-4eca-9740-a5cdf547daff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Immunoassay Control Level 2 |
| Version Model Number | 94102 |
| Company DUNS | 078742335 |
| Company Name | CLINIQA CORPORATION |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| GS1 | 00817238010417 [Primary] |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-04 |
| Device Publish Date | 2018-08-22 |
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| 00817238010677 - Protein 2 Calibration Verifier Set for the Roche Integra | 2020-02-10 Protein 2 Calibration Verifier Set for the Roche Integra |
| 00817238010684 - Protein 3 Calibration verifier Set for the Roche Integra | 2020-02-10 Protein 3 Calibration verifier Set for the Roche Integra |