← Back to catalogue
u-test Self-Contained Biological Indicator for Steam Sterilization (SCBI)
FDA UDIClass II (US FDA UDI)
by Maxill, Inc.
Identity
- Trade Name
- u-test Self-Contained Biological Indicator for Steam Sterilization (SCBI) FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Model / Reference
- 81154 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00060705811547 FDA UDI
- 510(k) Number
- K163144 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
u-test Self-Contained Biological Indicator for Steam Sterilization (SCBI) by Maxill, Inc. — Class II — FDA UDI — listed in FDA GUDID
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
- BIOlogical12 — HF Acquisition Co. LLC · Class II
- Safco Tru-Verify™ Monitor — Safco Dental Supply · Class II
- Bionova® — TERRAGENE S.A. · Class II
- Bionova® — TERRAGENE S.A. · Class II
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
- Maxill, Inc.
Sources (1)
- FDA UDI ded47276-892f-4184-ab4d-732a89a4ef59 34 fields · synced May 31, 2026