Giardia lamblia Antigen (stool) ELISA
- Primary DI
- 04048474034776
- Brand
- Giardia lamblia Antigen (stool) ELISA
- Company
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Model
- EIA-3477
- Catalog number
- EIA-3477
- Device description
- This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in fecal specimens
- Published
- 2023-08-29
- 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
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MHI | Giardia Spp. | Microbiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04048474034776 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04048474034776 | 04048474034776 | 4048474034776 |
GMDN Terms
| Term | Definition |
|---|
| Giardia lamblia antigen 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 antigens from the parasitic protozoan Giardia lamblia 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
- 317134468
- 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
- true
- 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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|---|
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| 00848838026881 | NA | REMEL, INC. | MHI | 2016-09-24 |
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| 05391516746328 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | MHI | 2016-09-18 |
| 05391516746335 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | MHI | 2016-09-18 |
| 50885380096738 | CARDINAL HEALTH | Cardinal Health 200, LLC | MHI | 2016-09-14 |
| 00857031002028 | GIARDIA II | TECHLAB, INC. | MHI | 2016-08-23 |
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| 00857031002165 | GIARDIA/CRYPTOSPORIDIUM QUIK CHEK | TECHLAB, INC. | MHI | 2016-08-20 |
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