Identity
- Trade Name
- Beckman Coulter® PK® Systems Bromelin FDA UDI
- Generic Name
- Bromelin immunohaematology reagent IVD FDA UDI
- Device Name
- Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System FDA UDI
- Model / Reference
- 17330 FDA UDI
- Description
- Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System FDA UDI
Identifiers
- Catalog Number
- 17330 FDA UDI
- Primary DI / UDI-DI
- 23661562173307 FDA UDI
- FDA Product Code
- KSK FDA UDI
- GMDN Term
- Bromelin immunohaematology reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9400 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bromelin immunohaematology reagent IVD
Beckman Coulter® PK® Systems Bromelin by Diagast — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bromelin immunohaematology reagent IVD.
- Bromelin for Erytype — Bio-Rad Medical Diagnostics GmbH · Class II
- Bromelin for Erytype — Bio-Rad Medical Diagnostics GmbH · Class II
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
- Diagast
Sources (1)
- FDA UDI 2e22ad18-2856-4f0e-a56e-b6825681c986 36 fields · synced May 30, 2026