Identity
- Trade Name
- STERLINK™ FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydorgen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60 degree celsius. FDA UDI
- Model / Reference
- BT96 FDA UDI
- Description
- Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydorgen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60 degree celsius. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800066500184 FDA UDI
- 510(k) Number
- K212193 FDA UDI
- FDA Product Code
- FRC FDA UDIJOJ 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
Sterlink™ by Plasmapp Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212193 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 |
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Manufacturer
- Manufacturer
- Plasmapp Co., Ltd.
Sources (1)
- FDA UDI 01205b52-8003-45cc-8c02-bc8b7ef7b647 35 fields · synced Jun 1, 2026