Identity
- Trade Name
- BeadCheck HEA Ref-pB, Bulk and Fill FDA UDI
- Generic Name
- Multiple blood group genotyping IVD, control FDA UDI
- Model / Reference
- 800-00229 FDA UDI
Identifiers
- Catalog Number
- 800-00229 FDA UDI
- Primary DI / UDI-DI
- 10888234102328 FDA UDI
- FDA Product Code
- PFK FDA UDI
- GMDN Term
- Multiple blood group genotyping 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood group genotyping IVD, control
BeadCheck HEA Ref-pB, Bulk and Fill by Bioarray Solutions Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple blood group genotyping IVD, control.
- Hemo-QC — HEMO BIOSCIENCE · Class II
- ID CORE CONTROL — PROGENIKA BIOPHARMA, SA · Class II
- BeadCheck HEA Ref-pA, Bulk and Fill — BIOARRAY SOLUTIONS LTD · Class II
- Precise TypeTM HEA BeadCheck Kit — BIOARRAY SOLUTIONS LTD · Class II
Cleared under the same submission
BK130050 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
- Bioarray Solutions Ltd
Sources (1)
- FDA UDI d690a9e0-457d-42f3-80db-bb87be75c1a1 35 fields · synced May 30, 2026