FDA UDI
In Commercial Distribution
🇺🇸 United States
Echinococcus multilocularis (Em18) IgG ELISA
DI: 07640158219317
·
Model: 9310
·
Bordier affinity products S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Echinococcus multilocularis (Em18) IgG ELISA
- Primary DI
- 07640158219317
- Version / Model
- 9310
- Catalog Number
- 9310
- Company Name
- Bordier affinity products S.A.
- Labeler DUNS
- 487811143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-17
- Public Version
- 1
- Public Version Date
- 2022-08-25
- Public Version Status
- New
- Public Device Record Key
- e997fadb-7e6a-49e9-830e-76512d6e5d40
Device Description
The Echinococcus multilocularis (Em18) ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus multilocularis antibodies in human serum samples. This test is intended for post-operative and/or post-therapeutic follow-up of infected patients.
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 |
|---|---|---|---|---|
| GPF | Antigen, Agglutinating, Echinococcus Spp. | Microbiology | 866.3200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52217 | Echinococcus multilocularis immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Echinococcus multilocularis in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Echinococcus multilocularis, a parasitic tapeworm associated with hydatid disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640158219317 | GS1 |
Customer Contacts
- Phone
- +41216333167
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 37 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius