| Primary Device ID | 00816879020212 |
| NIH Device Record Key | e312a7d3-8116-4091-96f8-913b92362e3d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Autostat II Anti-Nuclear Antibody (ANA) Screen |
| Version Model Number | FGA21 |
| Company DUNS | 010558476 |
| Company Name | HYCOR BIOMEDICAL 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816879020212 [Primary] |
| LIM | Test, Screening, For D Positive Fetal Rbc'S |
| 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 | 2016-09-26 |
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| 00816879020557 - Sage, Salvia officinalis | 2022-01-10 |
| 00816879020564 - Saffron | 2022-01-10 |
| 00816879020588 - Pepper, Green, Piper nigrum | 2022-01-10 |
| 00816879020663 - Lime, Citrus aurantiifolia | 2022-01-10 |
| 00816879020816 - Cheese, American (Defatted) | 2022-01-10 |
| 00816879020977 - Cefalexin | 2022-01-10 |
| 00816879022988 - Willow, Salix caprea | 2022-01-10 |