Legionella pneumophila (Group 1-6)
- Primary DI
- 00845533003551
- Brand
- Legionella pneumophila (Group 1-6)
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- FA15001
- Catalog number
- FA15001
- Device description
- The Legionella pneumophila (Group 1 - 6) is an indirect fluorescent antibody (IFA) assay designed for the detection of L. pneumophila antibodies in human serum, and is for In Vitro diagnostic use.
- Published
- 2026-05-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00845533003551 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845533003551 | 00845533003551 | 845533003551 | 0845533003551 |
GMDN Terms
| Term | Definition |
|---|
| Legionella pneumophila total 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 total antibodies to one or multiple serogroups of Legionella pneumophila in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 0 | 0 | |
Regulatory Flags
- DUNS number
- 080953946
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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