FDA UDI
In Commercial Distribution
🇺🇸 United States
Reagent A - CMV Brite™ Turbo kit
DI: 08717953022356
·
Model: VIR-CMV110 RA BDC
·
IQ Products B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reagent A - CMV Brite™ Turbo kit
- Primary DI
- 08717953022356
- Version / Model
- VIR-CMV110 RA BDC
- Catalog Number
- VIR-CMV110 RA BDC
- Company Name
- IQ Products B.V.
- Labeler DUNS
- 490578678
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- af8829dd-4790-46cb-9239-0b655c87f305
Device Description
Reagent A is a component of the CMV Brite™ Turbo kit which can be used in direct lysis of peripheral blood erythrocytes. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| 49710 | Cytomegalovirus (CMV) antigen IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717953022356 | GS1 |
Customer Contacts
- Phone
- +31505757000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991650 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius