Identity
- Trade Name
- Capture-CMV Indicator Red Cells FDA UDI
- Generic Name
- Cytomegalovirus (CMV) antigen IVD, reagent FDA UDI
- Device Name
- Capture-CMV Indicator Red Cells are part of the Capture-CMV test, and they are used to visualize the final reaction. FDA UDI
- Model / Reference
- 0066238 FDA UDI
- Description
- Capture-CMV Indicator Red Cells are part of the Capture-CMV test, and they are used to visualize the final reaction. FDA UDI
Identifiers
- Catalog Number
- 0066238 FDA UDI
- Primary DI / UDI-DI
- 10888234001232 FDA UDI
- 510(k) Number
- K910003 FDA UDI
- FDA Product Code
- LJO FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) antigen IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3175 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: Cytomegalovirus (CMV) antigen IVD, reagent
Capture-CMV Indicator Red Cells by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytomegalovirus (CMV) antigen IVD, reagent.
- Reagent A - CMV Brite™ Turbo kit — IQ Products B.V. · Class II
- CMV Brite™ Turbo Control Slides — IQ Products B.V. · Class II
- Reagent D - CMV Brite™ Turbo kit — IQ Products B.V. · Class II
- Reagent B - CMV Brite™ Turbo kit — IQ Products B.V. · Class II
- Reagent C - CMV Brite™ Turbo kit — IQ Products B.V. · Class II
- Reagent E - CMV Brite™ Turbo kit — IQ Products B.V. · Class II
- Capture-CMV Control set — IMMUCOR, INC. · Class II
- Capture-CMV — IMMUCOR, INC. · Class II
Cleared under the same submission
K910003 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 a1a9d07a-917b-4c10-9590-a213ac1ff4cb 37 fields · synced May 30, 2026