| Primary Device ID | 00850065007496 |
| NIH Device Record Key | 6cfe571e-10d6-40cb-8bfc-cbbbe441b83d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS |
| Version Model Number | 1023780 |
| Company DUNS | 045657305 |
| Company Name | HF ACQUISITION CO. LLC |
| 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 | 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 | true |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com | |
| Phone | 800-331-1984 |
| customerservice@healthfirst.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850065007496 [Primary] |
| FRC | Indicator, Biological Sterilization Process |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-01 |
| Device Publish Date | 2025-06-23 |
| 00850065007489 - SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS | 2025-07-01 |
| 00850065007496 - SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS | 2025-07-01 |
| 00850065007496 - SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS | 2025-07-01 |
| 00850065007434 - Criti-Kit 200-AI | 2024-06-24 |
| 00850065007465 - Criti-Kit Narcan Opioid Overdose Kit – 2 Doses | 2024-05-28 |
| 00850065007267 - SM ORGANIZER | 2024-01-08 |
| 00850065007274 - STAT KIT SM7 EMERGENCY MEDICAL KIT | 2024-01-08 |
| 00850065007281 - STAT KIT SM10 EMERGENCY MEDICAL KIT | 2024-01-08 |
| 00850065007298 - STAT KIT SM27 EMERGENCY MEDICAL KIT | 2024-01-08 |