| Primary Device ID | 00860006589714 |
| NIH Device Record Key | d7d6d20d-9b23-4caa-890c-0f05a59a1a47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit |
| Version Model Number | 0505-0260 |
| Company DUNS | 106267123 |
| Company Name | Lgc Clinical Diagnostics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860006589714 [Primary] |
| OHQ | Multi-Analyte Controls Unassayed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-25 |
| Device Publish Date | 2023-07-17 |
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