Identity
- Trade Name
- SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Model / Reference
- 1023770 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850065007489 FDA UDI
- 510(k) Number
- K032914 FDA UDI
- FDA Product Code
- FRC FDA UDI
- GMDN Term
- Biological sterilization indicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological sterilization indicator
Sporetraq Mail-In Spore Testing Service, 12 Tests by HF Acquisition Co. LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biological sterilization indicator.
- VERIFY — STERIS CORPORATION · Class II
- SPORVIEW SELF-CONTAINED STEAM BI — Spsmedical Supply Corp. · Class II
- PASSPORT MAIL-IN SYSTEM — Spsmedical Supply Corp. · Class II
- Attest™ — 3M COMPANY · Class II
- Safco Tru-Verify™ Monitor — Safco Dental Supply · Class II
- Bionova® — TERRAGENE S.A. · Class II
- Bionova® — TERRAGENE S.A. · Class II
- Dual Spore Strips - Test — MESA LABORATORIES, INC. · Class II
Cleared under the same submission
K032914 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HF Acquisition Co. LLC
Sources (1)
- FDA UDI 402aaa27-2f6e-4ad7-b3ef-ad8cd4fb8d17 34 fields · synced Jun 6, 2026