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Starswab II Bacteriology Culture Collection and Transport System
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Starswab II Bacteriology Culture Collection and Transport System FDA UDI
- Generic Name
- General specimen collection kit IVD, clinical FDA UDI
- Device Name
- Starswab II Bacteriology Culture Collection and Transport System with Amies Clear Gel and double plastic shaft rayon tip swab applicators. FDA UDI
- Model / Reference
- SP130D FDA UDI
- Description
- Starswab II Bacteriology Culture Collection and Transport System with Amies Clear Gel and double plastic shaft rayon tip swab applicators. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840165400105 FDA UDI
- FDA Product Code
- LIO FDA UDI
- GMDN Term
- General specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General specimen collection kit IVD, clinical
Starswab II Bacteriology Culture Collection and Transport System by Pretium Canada Packaging ULC — Class I — FDA UDI — listed in FDA GUDID
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Pretium Canada Packaging ULC
Sources (1)
- FDA UDI 54158025-7dde-469e-a4af-fc7c0e98e88c 33 fields · synced Jun 8, 2026