FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IFA: Legionella Mosaic 4 (IgG)
DI: 04049016089520
·
Model: FI 2150-1010-4 G
·
EUROIMMUN Medizinische Labordiagnostika AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IFA: Legionella Mosaic 4 (IgG)
- Primary DI
- 04049016089520
- Version / Model
- FI 2150-1010-4 G
- Company Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Labeler DUNS
- 322209263
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 3
- Public Version Date
- 2022-07-21
- Public Version Status
- Update
- Public Device Record Key
- 487737e3-8f7d-4509-ad64-9e12c1172e0c
- Distribution End Date
- 2022-05-27
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | Microbiology | 866.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62353 | Multiple Legionella species 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 multiple species of Legionella bacteria in a clinical specimen, using a fluorescent immunoassay method. Legionella species intended to be detected may include Legionella pneumophila, L. longbeachae, L. jordanis, L. bozemanii, L. gormanii, L. micdadei, and L. dumoffii which are associated with pneumonia-like respiratory infection and Legionnaires' disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049016089520 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius