FDA UDI
In Commercial Distribution
🇺🇸 United States
MERIFLUOR VZV (Vericella-Zoster Virus)
DI: 00840733101212
·
Model: 500113
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MERIFLUOR VZV (Vericella-Zoster Virus)
- Primary DI
- 00840733101212
- Version / Model
- 500113
- Catalog Number
- 500113
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e735a67b-0db8-4815-8553-eaa5d2825f26
Device Description
MERIFLUOR VZV is an in vitro direct immunofluorescent detection procedure for the detection of varicella-zoster virus (VZV) in vesicle smears and biopsy specimens. in addition, the reagent can be used to confirm the presence of VZV in cell culture.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| GQX | Antiserum, Cf, Varicella-Zoster | Microbiology | 866.3900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49615 | Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from varicella-zoster virus (VZV) in a clinical specimen, using a direct fluorescent test (DFT). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840733101212 | GS1 |
Customer Contacts
- Phone
- 513-271-3700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K841526 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius