| Primary Device ID | 00816610020402 |
| NIH Device Record Key | b70b23a1-5626-4e27-a607-5992c7e8a92e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLIAWAIVED INC |
| Version Model Number | THYROCHEK-120-A-KIT |
| Catalog Number | THYROCHEK-120-A-KIT |
| Company DUNS | 969635304 |
| Company Name | Cliawaived, 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com | |
| Phone | 1-888-882-7739 |
| info@cliawaived.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816610020402 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-08 |
| Device Publish Date | 2019-03-29 |
| 00816610020440 | CLIAWaived Inc. Thyroid Test Rapid TSH cassette (whole blood) |
| 00816610020402 | Thyrochek One-Step Whole Blood Rapid TSH Assay |
| 00183278000436 | CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 in |
| 00183278000443 | CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Professional Use Onl |