| Primary Device ID | 00816879020069 |
| NIH Device Record Key | a73a28a1-da77-49d0-b13b-33bbedc80b62 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Autostat II IgA Rheumatoid Factor |
| Version Model Number | FGA06 |
| Catalog Number | FGA06 |
| 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 | 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 |
| 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 | 00816879020069 [Primary] |
| DHR | System, Test, Rheumatoid Factor |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-17 |
| Device Publish Date | 2018-08-15 |
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