FDA UDI
In Commercial Distribution
🇺🇸 United States
Legionella pneumophila IgG ELISA
DI: 04048474056457
·
Model: EIA-5645
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Legionella pneumophila IgG ELISA
- Primary DI
- 04048474056457
- Version / Model
- EIA-5645
- Catalog Number
- EIA-5645
- 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
- 2019-06-10
- Public Version
- 3
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- 550dc24b-153c-4255-b758-271f80cc0600
Device Description
The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
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
- 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 |
|---|---|---|---|---|
| MJH | LEGIONELLA, SPP., ELISA | Microbiology | 866.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51079 | Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048474056457 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius