Identity
- Trade Name
- Beckman Coulter® PK® Systems Control FDA UDI
- Generic Name
- Antisera matrix (non-reactive) IVD, control FDA UDI
- Device Name
- Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System FDA UDI
- Model / Reference
- 17317 FDA UDI
- Description
- Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System FDA UDI
Identifiers
- Catalog Number
- 17317 FDA UDI
- Primary DI / UDI-DI
- 23661562173178 FDA UDI
- FDA Product Code
- KSF FDA UDI
- GMDN Term
- Antisera matrix (non-reactive) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9650 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: Antisera matrix (non-reactive) IVD, control
Beckman Coulter® PK® Systems Control by Diagast — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antisera matrix (non-reactive) IVD, control.
- Seraclone Control AB0+Rh — Bio-Rad Medical Diagnostics GmbH · Class II
- IH-Card Control — Bio-Rad Medical Diagnostics GmbH · Class II
- ALBAcheck - BGS Monoclonal Control — ALBA BIOSCIENCE LIMITED · Class II
- MTS — MICRO TYPING SYSTEMS, INC · Class II
- ORTHO — Ortho-Clinical Diagnostics · Class I
- Neg Control — DIAGAST · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagast
Sources (1)
- FDA UDI ecbada22-286e-4b0b-b918-4202d8af06ab 36 fields · synced Jun 6, 2026