FDA UDI
In Commercial Distribution
🇺🇸 United States
Measles Virus IgG Avidity ELISA
DI: 00404847459678
·
Model: EIA-5967
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Measles Virus IgG Avidity ELISA
- Primary DI
- 00404847459678
- Version / Model
- EIA-5967
- Catalog Number
- EIA-5967
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-07
- Public Version
- 2
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- bc53a78d-53f2-4e64-b99d-a0610132cf7d
Device Description
The Measles Virus IgG Avidity ELISA is intended to indicate the Measles-specific IgG avidity in human serum or plasma (citrate, heparin) to differentiate between acute and past 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
- Yes
- 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 |
|---|---|---|---|---|
| LJB | Enzyme linked immunoabsorbent assay, rubeola IgG | Microbiology | 866.3520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49301 | Measles virus immunoglobulin A (IgA)/IgG/IgM 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 A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Measles virus 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 | 00404847459678 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius