GeroaDX
- Primary DI
- 08437029987012
- Brand
- GeroaDX
- Company
- GEROA DIAGNOSTICS SOCIEDAD LIMITADA.
- Model
- 1
- Device description
- ELISA Kit for Human Lactoferrin For In Vitro Diagnostic Use
- Published
- 2025-12-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| DEG | Lactoferrin, Antigen, Antiserum, Control |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DEG | Lactoferrin, Antigen, Antiserum, Control | Immunology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08437029987012 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08437029987012 | 08437029987012 | 8437029987012 |
GMDN Terms
| Term | Definition |
|---|
| Lactoferrin 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 lactoferrin in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 466966807
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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
- true
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| B24280LACHUFCSET0 | Lactoferrin CLIA Re-Calibrator and Control Set | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | DEG | 2025-06-06 |
| B24280LACHUFC1000 | ALPCO Lactoferrin CLIA Kit | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | DEG | 2025-03-03 |
| 04048474036022 | Anti-Lactoferrin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | DEG | 2023-08-29 |
| 04050598010406 | Lactoferrin ELISA | Immundiagnostik AG | DEG | 2023-06-21 |
| 04050598010413 | Lactoferrin ELISA | Immundiagnostik AG | DEG | 2023-06-21 |
| 00404847436020 | Anti-Lactoferrin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | DEG | 2021-07-28 |
| 00857031002530 | LEUKO EZ VUE | TECHLAB, INC. | DEG | 2020-01-24 |
| 00857031002356 | LACTOFERRIN EZ VUE | TECHLAB, INC. | DEG | 2019-05-31 |
| 00857031002585 | QuickVue TLI Lactoferrin Test | TECHLAB, INC. | DEG | 2019-05-30 |
| 00857031002080 | LACTOFERRIN CHEK | TECHLAB, INC. | DEG | 2019-05-29 |
| 00857031002189 | LACTOFERRIN EZ VUE | TECHLAB, INC. | DEG | 2019-05-29 |
| 00857031002097 | LACTOFERRIN SCAN | TECHLAB, INC. | DEG | 2019-04-12 |
| 00857031002172 | LEUKO EZ VUE | TECHLAB, INC. | DEG | 2019-04-12 |
| 00857031002271 | LACTOFERRIN CHEK | TECHLAB, INC. | DEG | 2019-04-12 |
| 00857031002288 | LACTOFERRIN SCAN | TECHLAB, INC. | DEG | 2019-04-12 |