Identity
- Trade Name
- RIDASCREEN® Echinococcus IgG FDA UDI
- Generic Name
- Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The RIDASCREEN® Echinococcus IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Echinococcus granulosus und Echinococcus multilocularis in human serum. The test should be used for confirmation purposes when there is a suspected case of infection with Echinococcus. FDA UDI
- Model / Reference
- K7621 FDA UDI
- Description
- The RIDASCREEN® Echinococcus IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Echinococcus granulosus und Echinococcus multilocularis in human serum. The test should be used for confirmation purposes when there is a suspected case of infection with Echinococcus. FDA UDI
Identifiers
- Catalog Number
- K7621 FDA UDI
- Primary DI / UDI-DI
- 04049095110511 FDA UDI
- GMDN Term
- Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
RIDASCREEN® Echinococcus IgG by R-Biopharm AG — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- R-Biopharm AG
Sources (1)
- FDA UDI da32e4d4-b481-4352-869d-a1460cc3c7aa 35 fields · synced Jun 1, 2026