FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test Kit
DI: 08717953022325
·
Model: VIR-BDC100 CHS
·
IQ Products B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test Kit
- Primary DI
- 08717953022325
- Version / Model
- VIR-BDC100 CHS
- Catalog Number
- VIR-BDC100 CHS
- Company Name
- IQ Products B.V.
- Labeler DUNS
- 490578678
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2022-09-14
- Public Version Status
- Update
- Public Device Record Key
- 8a0fd8b3-4b6a-432a-a7e4-4d3c25c5af46
- Distribution End Date
- 2021-12-31
Device Description
The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | Microbiology | 866.3175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49707 | Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717953022325 | GS1 |
Customer Contacts
- Phone
- +31505757000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius