| Primary Device ID | 00860013899295 |
| NIH Device Record Key | 210d09cc-77b3-4610-9c14-d42f73058ba6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colofit Test Kit |
| Version Model Number | DTCF01 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860013899295 [Primary] |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-14 |
| Device Publish Date | 2025-05-06 |
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| 10860013899285 - Paternity Test Kit 25 | 2025-05-14 Paternity Test Kit 25/cs |
| 00860013899295 - Colofit Test Kit | 2025-05-14Colofit Test Kit detector for colorectal cancer |
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| 00860013969516 - Kidney Health Test Kit 2 | 2025-05-14 These kits are designed to detect early signs of kidney damage or disease by analyzing your urine, blood, or both. |
| 00860013969523 - Kidney Health Test Kit 3 | 2025-05-14 These kits are designed to detect early signs of kidney damage or disease by analyzing your urine, blood, or both. |
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