Identity
- Trade Name
- CMV Brite™ Turbo Control Slides FDA UDI
- Generic Name
- Cytomegalovirus (CMV) antigen IVD, reagent FDA UDI
- Device Name
- CMV Brite™ Turbo Control Slides are a component of the CMV Brite™ Turbo kit which can be used as a control in the fluorescence staining of this kit. Slides with a positive and negative side are provided in a sealed pouch with desiccant and are ready to use. Positive side contains pp65 positive sf9 cells. Cells are fixated. 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-CMV CS05 BDC FDA UDI
- Description
- CMV Brite™ Turbo Control Slides are a component of the CMV Brite™ Turbo kit which can be used as a control in the fluorescence staining of this kit. Slides with a positive and negative side are provided in a sealed pouch with desiccant and are ready to use. Positive side contains pp65 positive sf9 cells. Cells are fixated. 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-CMV CS05 BDC FDA UDI
- Primary DI / UDI-DI
- 08717953022318 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
CMV Brite™ Turbo Control Slides by IQ Products B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytomegalovirus (CMV) antigen IVD, reagent.
- Capture-CMV Control set — IMMUCOR, INC. · Class II
- Capture-CMV Indicator Red Cells — IMMUCOR, INC. · Class II
- Capture-CMV — IMMUCOR, INC. · Class II
- Capture-CMV — IMMUCOR, INC. · Class II
- Reagent A - CMV Brite™ Turbo kit — 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
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 2e1ad7c9-4f58-4603-a07f-e1a25a0ee05c 37 fields · synced Jun 6, 2026