| Primary Device ID | 00742860100345 |
| NIH Device Record Key | 387cfaef-aa3e-454a-9492-d23d2a98031d |
| Commercial Distribution Discontinuation | 2019-09-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Acucy Calibration Device |
| Version Model Number | 1031 |
| Company DUNS | 966812344 |
| Company Name | SEKISUI DIAGNOSTICS, LLC |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00742860100345 [Primary] |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-02 |
| Device Publish Date | 2019-09-24 |
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| 00742860100062 - OSOM BV Blue Control Kit | 2026-01-06 |
| 00742860000065 - OSOM Flu SARS-CoV-2 Combo Test | 2025-12-23 OSOM Flu SARS-CoV-2 Combo Test |
| 10742860100663 - OSOM RSV Test Home | 2025-05-27 OSOM RSV Test |
| 00628063401291 - Acetaminophen | 2023-05-16 |
| 00628063401307 - Acetaminophen Calibrator | 2023-05-16 |
| 00628063401314 - Alinity c Acetaminophen | 2023-05-16 |
| 00628063401321 - Alinity c Acetaminophen Calibrator | 2023-05-16 |