Identity
- Trade Name
- corQC EXTEND 1, 2, and 3 FDA UDI
- Generic Name
- Multiple immunohaematology test IVD, control FDA UDI
- Device Name
- corQC EXTEND 1, 2, and 3 is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a three vial set. FDA UDI
- Model / Reference
- 0002417 FDA UDI
- Description
- corQC EXTEND 1, 2, and 3 is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a three vial set. FDA UDI
Identifiers
- Catalog Number
- 0002417 FDA UDI
- Primary DI / UDI-DI
- 10888234000341 FDA UDI
- FDA Product Code
- KSF FDA UDI
- GMDN Term
- Multiple immunohaematology test 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
Yes
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 immunohaematology test IVD, control
corQC EXTEND 1, 2, and 3 by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple immunohaematology test IVD, control.
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- HAEMATOLOGY CONTROL - LEVEL 1 (HAEM CNTL - LEVEL 1) — Randox Laboratories, Ltd. · Class II
- HAEMATOLOGY CONTROL - LEVEL 3 (HAEM CNTL - LEVEL 3) — Randox Laboratories, Ltd. · Class II
Cleared under the same submission
BK070039 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
- Immucor, Inc.
Sources (1)
- FDA UDI f44d48c1-9144-42a5-850d-ca47b0def566 37 fields · synced Jun 6, 2026