FDA UDI
In Commercial Distribution
🇺🇸 United States
Mumps Virus IgG
DI: 00845533002929
·
Model: I-MUV01G
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Mumps Virus IgG
- Primary DI
- 00845533002929
- Version / Model
- I-MUV01G
- Catalog Number
- I-MUV01G
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-18
- Public Version
- 1
- Public Version Date
- 2026-02-26
- Public Version Status
- New
- Public Device Record Key
- d5ef2b89-2bf3-4c37-8025-80ac895c4bc2
Device Description
The Indirect Fluorescence Assay (IFA) for Mumps Virus IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to mumps virus in human serum or plasma. Detection of mumps virus IgG antibody in humans can be used as an aid in the diagnosis of current infection with this virus and can provide serological evidence of previous mumps infection.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49333 | Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay | 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 Mumps virus 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 | 00845533002929 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius