| Primary Device ID | 00860009616004 |
| NIH Device Record Key | b0c22522-33e2-403e-b5b2-637763e85933 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QFT Kit |
| Version Model Number | 2208310032 |
| Company DUNS | 111296701 |
| Company Name | Ditek Consulting, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009616004 [Primary] |
| GS1 | 20860009616008 [Package] Package: Case [24 Units] In Commercial Distribution |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-26 |
| Device Publish Date | 2024-08-16 |
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