| Primary Device ID | 00810042684324 | 
| NIH Device Record Key | 9d342f73-e54b-44fd-a91d-6267b199d20e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cliawaived | 
| Version Model Number | Multitox-PC-25F | 
| Catalog Number | Multitox-PC-25F | 
| Company DUNS | 028007698 | 
| Company Name | BIOCHEMICAL DIAGNOSTICS INC | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00810042684324 [Primary] | 
| DIF | Drug Mixture Control Materials | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-11-29 | 
| Device Publish Date | 2024-11-21 | 
| 00810042684324 | Cliawaived™ Inc Multitox Urine, POSITIVE QC, 25mL | 
| 00810042684362 | Positive QC, 25mL | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CLIAWAIVED  77493425  not registered Dead/Abandoned | CLIAWAIVED, INC. 2008-06-06 |