Identity
- Trade Name
- Giardia lamblia Antigen (stool) ELISA FDA UDI
- Generic Name
- Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in fecal specimens FDA UDI
- Model / Reference
- EIA-3477 FDA UDI
- Description
- This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in fecal specimens FDA UDI
Identifiers
- Catalog Number
- EIA-3477 FDA UDI
- Primary DI / UDI-DI
- 04048474034776 FDA UDI
- FDA Product Code
- MHI FDA UDI
- GMDN Term
- Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3220 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Giardia lamblia Antigen (stool) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID
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 | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI e587da29-a4c5-4d50-b013-ee425cc27a69 37 fields · synced Jun 1, 2026