Identity
- Trade Name
- Smart Read EZTest Biological Test Pack FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- Mesa labs Smart-Read EZTest Biological Test Pack with Instant Readout Integrator FDA UDI
- Model / Reference
- 10e6/25 controls FDA UDI
- Description
- Mesa labs Smart-Read EZTest Biological Test Pack with Instant Readout Integrator FDA UDI
Identifiers
- Catalog Number
- SRSP6/25 FDA UDI
- Primary DI / UDI-DI
- M985SRSP6250 FDA UDI
- 510(k) Number
- K103000 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
No
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
Smart Read EZTest Biological Test Pack by Mesa Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103000 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
- Mesa Laboratories, Inc.
Sources (1)
- FDA UDI 273a86d9-694e-42be-814c-af064725eb95 35 fields · synced Jun 8, 2026