Identity
- Trade Name
- Reagent E - CMV Brite™ Turbo kit FDA UDI
- Generic Name
- Cytomegalovirus (CMV) antigen IVD, reagent FDA UDI
- Device Name
- Reagent E is a component of the CMV Brite™ Turbo kit which can be used in immunofluorescence staining. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA. FDA UDI
- Model / Reference
- VIR-CMV110 RE BDC FDA UDI
- Description
- Reagent E is a component of the CMV Brite™ Turbo kit which can be used in immunofluorescence staining. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA. FDA UDI
Identifiers
- Catalog Number
- VIR-CMV110 RE BDC FDA UDI
- Primary DI / UDI-DI
- 08717953022394 FDA UDI
- 510(k) Number
- K991650 FDA UDI
- FDA Product Code
- LIN 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cytomegalovirus (CMV) antigen IVD, reagent
Reagent E - CMV Brite™ Turbo kit by IQ Products B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cytomegalovirus (CMV) antigen IVD, reagent.
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- Capture-CMV — IMMUCOR, INC. · Class II
- Capture-CMV — IMMUCOR, INC. · Class II
- 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
Cleared under the same submission
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
- IQ Products B.V.
Sources (1)
- FDA UDI 7f516429-7bfb-430b-b847-3e11a69d45fe 37 fields · synced May 29, 2026