Identity
- Trade Name
- SporView® Self-contained Biological Indicator FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- SCBI 10^6 STEAM, 25/BX FDA UDI
- Model / Reference
- SCS-026-I FDA UDI
- Description
- SCBI 10^6 STEAM, 25/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224721528 FDA UDI
- 510(k) Number
- K111515 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
SporView® Self-contained Biological Indicator by Crosstex International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Biological sterilization indicator.
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- Bionova® — TERRAGENE S.A. · Class II
Cleared under the same submission
K111515 also covers:
- ConFirm™ 24 In-Office Biological Monitoring System — CROSSTEX INTERNATIONAL, INC.
- "U-test BI LR Biological Indicator LR" — MAXILL, INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Safco Tru-Verify™ Monitor — Safco Dental Supply
- Safco Tru-Verify™ Monitor — Safco Dental Supply
- ConFirm 24 Steam Biological Indicators — Spsmedical Supply Corp.
- Getinge Self-Contained BI Steam Vial Box — Spsmedical Supply Corp.
- SPORVIEW PLUS SELF-CONTAINED STARTER KIT — Spsmedical Supply Corp.
- SPORVIEW SELF-CONTAINED STARTER KIT — Spsmedical Supply Corp.
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 |
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Manufacturer
- Manufacturer
- Crosstex International, Inc.
Sources (1)
- FDA UDI e3c2cacf-13d5-44b5-80bb-6675f3709e30 35 fields · synced Jun 6, 2026