Giardia lamblia Antigen (stool) ELISA
- Primary DI
- 00840239034779
- Brand
- Giardia lamblia Antigen (stool) ELISA
- Company
- DRG International Inc
- 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
- 2023-08-24
- 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 |
|---|
| 00840239034779 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840239034779 | 00840239034779 | 840239034779 | 0840239034779 |
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 | |
Contacts
| Phone | Email |
|---|
| 9735647555 | corpoffice@drg-international.com |
Regulatory Flags
- DUNS number
- 075150847
- 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
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 04048474059557 | 21-Hydroxylase Autoantibody ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | MHI | 2023-09-01 |
| 04048474034776 | Giardia lamblia Antigen (stool) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | MHI | 2023-08-29 |
| 00840239060594 | Giardia/Cryptosporidium Ag (stool) ELISA | DRG International Inc | MHI | 2023-08-26 |
| 00083059070699 | Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | MHI | 2020-07-01 |
| 00083059150155 | EZ-GIARDIA One-Step Giardia Test | BIOMERICA, INC. | MHI | 2020-07-01 |
| 00742860100017 | ImmunoStat G/C 30 Test Kit | SEKISUI DIAGNOSTICS, LLC | MHI | 2017-01-10 |
| 08305900070699 | Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | MHI | 2016-12-08 |
| 08305901501154 | EZ-GIARDIA One-Step Giardia Test | BIOMERICA, INC. | MHI | 2016-12-08 |
| 00848838026850 | NA | REMEL, INC. | MHI | 2016-09-24 |
| 00848838026867 | NA | REMEL, INC. | MHI | 2016-09-24 |
| 00848838026874 | NA | REMEL, INC. | MHI | 2016-09-24 |
| 00848838026881 | NA | REMEL, INC. | MHI | 2016-09-24 |
| 00848838026997 | NA | OXOID LIMITED | MHI | 2016-09-24 |
| 00848838027000 | NA | OXOID LIMITED | MHI | 2016-09-24 |
| 00848838027017 | NA | OXOID LIMITED | MHI | 2016-09-24 |
| 20613647000308 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | MHI | 2016-09-24 |
| 00840733101113 | MERIFLUOR Cryptosporidium/Giardia | MERIDIAN BIOSCIENCE, INC. | MHI | 2016-09-23 |
| 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 |
| 00857031002295 | GIARDIA II | TECHLAB, INC. | MHI | 2016-08-23 |
| 00857031002165 | GIARDIA/CRYPTOSPORIDIUM QUIK CHEK | TECHLAB, INC. | MHI | 2016-08-20 |
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