FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Ureaplasma urealyticum IgG ELISA
DI: 00404847446234
·
Model: EIA-4623
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ureaplasma urealyticum IgG ELISA
- Primary DI
- 00404847446234
- Version / Model
- EIA-4623
- Catalog Number
- EIA-4623
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-07
- Public Version
- 2
- Public Version Date
- 2023-11-07
- Public Version Status
- Update
- Public Device Record Key
- fb1ea48d-f03c-4cbf-ad7c-014c45a14099
- Distribution End Date
- 2023-11-06
Device Description
The DRG Ureaplasma urealyticum IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Ureaplasma urealyticum in serum and plasma.
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 |
|---|---|---|---|---|
| LJZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, MYCOPLASMA SPP. | Microbiology | 866.3375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51830 | Ureaplasma urealyticum 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 Ureaplasma urealyticum bacteria 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 | 00404847446234 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius