| Primary Device ID | 20860011770231 |
| NIH Device Record Key | b1071443-811f-40db-a862-a2e05004ce13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIPS Combo Collection Kit |
| Version Model Number | 131261 |
| 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 | 20860011770231 [Primary] |
| 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 | 2025-05-09 |
| Device Publish Date | 2025-05-01 |
| 00860011770282 - Kidney Stone Collection Kit | 2025-09-19 Kidney Stone Collection Kit (146225) |
| 00860013969554 - Ditek BioBank Kit (Labcorp) | 2025-09-05 BioBank Kit |
| 10860013969544 - High Altitude QuantiFERONTest Kit | 2025-06-25 High Altitude QuantiFeron Test Kit |
| 00860013969530 - NMS Umbilical Cord Kit | 2025-06-17 NMS Umbilical Cord Kit |
| 10860013899261 - Paternity Test Kit 50 | 2025-05-14 Paternity Test Kit 50/cs |
| 00860013899271 - Paternity Test Kit 1 | 2025-05-14 Paternity Test Kit 1 Single test |
| 10860013899285 - Paternity Test Kit 25 | 2025-05-14 Paternity Test Kit 25/cs |
| 00860013899295 - Colofit Test Kit | 2025-05-14 Colofit Test Kit detector for colorectal cancer |