| Primary Device ID | 00852553007261 |
| NIH Device Record Key | a3c5be79-b6bc-49ab-849e-74d3d4fbabf2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ammonia / Iron Standard, Level C |
| Version Model Number | 9043 |
| Company DUNS | 189023351 |
| Company Name | VERICHEM LABORATORIES, 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-552-5859 |
| customerservice@verichemlabs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852553007261 [Primary] |
| JIX | Calibrator, Multi-Analyte Mixture |
| 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 | 2018-01-16 |
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| 00852553007018 - Matrix Plus Cholestereol Reference Kit | 2018-07-06 Calibrator / Calibration Verifier |
| 00852553007025 - HDL Cholesterol Verifier Kit | 2018-07-06 |
| 00852553007032 - Urine Uric Acid Standard Kit | 2018-07-06 calibrator / calibration verifier |
| 00852553007049 - Enzymer Verifier Kit | 2018-07-06 Calibration Verifier |
| 00852553007056 - Enzymer ER Verifier Kit | 2018-07-06 Calibration Verifier |
| 00852553007063 - Bilirubin Standard Kit | 2018-07-06 Calibrator / Calibration Verifier |
| 00852553007070 - Bilirubin Standard, Level F | 2018-07-06 Calibrator / Calibration Verifier |