Identity
- Trade Name
- MALDI Biotyper-BD sirius CA System FDA UDI
- Generic Name
- Microbial identification mass spectrometry system IVD FDA UDI
- Device Name
- Biotyper system for clinical use in the USA, with smartbeam laser. FDA UDI
- Model / Reference
- 1890133 FDA UDI
- Description
- Biotyper system for clinical use in the USA, with smartbeam laser. FDA UDI
Identifiers
- Catalog Number
- 1890133 FDA UDI
- Primary DI / UDI-DI
- 04251204326175 FDA UDI
- 510(k) Number
- K163536 FDA UDI
- FDA Product Code
- PEX FDA UDI
- GMDN Term
- Microbial identification mass spectrometry system IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3361 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microbial identification mass spectrometry system IVD
MALDI Biotyper-BD sirius CA System by Bruker Daltonik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Bruker Daltonik GmbH
Sources (1)
- FDA UDI cf0806b8-49f1-4812-ac50-37ca7d96fdb0 37 fields · synced May 30, 2026