FDA UDI
In Commercial Distribution
🇺🇸 United States
NovaLisa Respiratory Syncytial Virus IgG
DI: ENTIRSVG03800
·
Model: RSVG0380
·
Gold Standard Diagnostics Frankfurt GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NovaLisa Respiratory Syncytial Virus IgG
- Primary DI
- ENTIRSVG03800
- Version / Model
- RSVG0380
- Catalog Number
- RSVG0380
- Company Name
- Gold Standard Diagnostics Frankfurt GmbH
- Labeler DUNS
- 330328514
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-26
- Public Version
- 2
- Public Version Date
- 2024-09-10
- Public Version Status
- Update
- Public Device Record Key
- 280ff5d4-3a86-434f-b395-d4a2ed5e9dae
Device Description
The Respiratory Syncytial Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against respiratory syncytial virus in human serum or plasma (citrate, heparin).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MCE | Respiratory Syncytial Virus - Elisa | Microbiology | 866.3480 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49513 | Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to respiratory syncytial virus (RSV) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ENTIRSVG03800 | HIBCC |
Customer Contacts
- Phone
- +1(888)977-4739
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius