FDA UDI
In Commercial Distribution
🇺🇸 United States
ZosterGent VZV Identification Reagent
DI: 00860002913551
·
Model: ZG-VL-US
·
VIRO RESEARCH, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- ZosterGent VZV Identification Reagent
- Primary DI
- 00860002913551
- Version / Model
- ZG-VL-US
- Catalog Number
- ZG-VL5-US
- Company Name
- VIRO RESEARCH, LLC
- Labeler DUNS
- 111651798
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-10-30
- Public Version
- 1
- Public Version Date
- 2020-11-09
- Public Version Status
- New
- Public Device Record Key
- 6cbbd847-b7e4-4426-84cc-320d023d9297
Device Description
ZosterGent VZV Identification Reagent Test (5) 3 mL Vials, in Ziplock Pouch
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
- Yes
- 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 |
|---|---|---|---|---|
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | Microbiology | 866.3900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49620 | Varicella-zoster virus (VZV) 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 varicella-zoster virus (VZV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00860002913506 | GS1 | ||||
| Primary | 00860002913551 | GS1 |
Customer Contacts
- Phone
- 888-626-2047
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942743 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius