Identity
- Trade Name
- Filled Vial, Clean-up, 330uL FDA UDI
- Generic Name
- Multiple blood group genotyping IVD, reagent FDA UDI
- Model / Reference
- 800-00191 FDA UDI
Identifiers
- Catalog Number
- 800-00191 FDA UDI
- Primary DI / UDI-DI
- 10888234100621 FDA UDI
- FDA Product Code
- PEP FDA UDI
- GMDN Term
- Multiple blood group genotyping IVD, reagent FDA UDI
Classification
- Device Class
- Class III 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, reagent
Filled Vial, Clean-up, 330uL by Bioarray Solutions Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple blood group genotyping IVD, reagent.
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Cleared under the same submission
BP130026 also covers:
- Filled Vial, HEA 1.2 PCR Mix — BIOARRAY SOLUTIONS LTD
- Filled Vial, HotStarTaq DNA Polymerase — BIOARRAY SOLUTIONS LTD
- Filled Vial, Lambda Exonuclease — BIOARRAY SOLUTIONS LTD
- Filled Vial, Negative Control 1mL — BIOARRAY SOLUTIONS LTD
- Filled Vial, eMAPTM Elongation Mix — BIOARRAY SOLUTIONS LTD
- Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate — BIOARRAY SOLUTIONS LTD
- Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides — BIOARRAY SOLUTIONS LTD
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 III | Pending data |
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Manufacturer
- Manufacturer
- Bioarray Solutions Ltd
Sources (1)
- FDA UDI 4c74e21d-6431-4a68-baeb-9dd2488e2bd1 35 fields · synced May 30, 2026