| Primary Device ID | 00844509001003 |
| NIH Device Record Key | 8ad0f517-b14b-4941-ab9b-a5f0dc6c53f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A1c-Cellular Linearity |
| Version Model Number | 285536 |
| Catalog Number | 285536 |
| Company DUNS | 072915986 |
| Company Name | STRECK, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | 1-800-228-6090 |
| custserv@streck.com |
| Total Volume | 2 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844509001003 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-19 |
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