FDA UDI
In Commercial Distribution
🇺🇸 United States
Mumps Virus IgG ELISA
DI: 00840239038463
·
Model: EIA-3846
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mumps Virus IgG ELISA
- Primary DI
- 00840239038463
- Version / Model
- EIA-3846
- Catalog Number
- EIA-3846
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-20
- Public Version
- 3
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- 6b4f3c4a-b2bb-4aa9-ab4c-a1d5c7ab7881
Device Description
The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LJY | ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS | Microbiology | 866.3380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49338 | Mumps 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 Mumps 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 | 00840239038463 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Conjugate | ||
| Device Size Text, specify | Diluent G | ||
| Total Volume | 20 | Milliliter | |
| Device Size Text, specify | Wash Buffer | ||
| Device Size Text, specify | Cut Off | ||
| Total Volume | 100 | Milliliter | |
| Total Volume | 15 | Milliliter | |
| Total Volume | 50 | Milliliter | |
| Total Volume | 3 | Milliliter | |
| Device Size Text, specify | Stop Solution | ||
| Device Size Text, specify | Controls +/- | ||
| Device Size Text, specify | Substrate TMB | ||
| Total Volume | 2 | Milliliter |