Identity
- Trade Name
- Haemophilus influenza B IgG ELISA FDA UDI
- Generic Name
- Haemophilus influenzae culture isolate antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Enzyme immunoassay for the determination of IgG antibodies against polyribosylribitolphosphate (PRP) of Haemophilus influenzae type B in human serum and plasma. FDA UDI
- Model / Reference
- EIA-2530 FDA UDI
- Description
- Enzyme immunoassay for the determination of IgG antibodies against polyribosylribitolphosphate (PRP) of Haemophilus influenzae type B in human serum and plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-2530 FDA UDI
- Primary DI / UDI-DI
- 04048474025309 FDA UDI
- FDA Product Code
- GRP FDA UDI
- GMDN Term
- Haemophilus influenzae culture isolate antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3300 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
No
FDA UDI
Haemophilus influenza B IgG 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 044fbf34-ac08-4aba-b41f-017f45faba55 37 fields · synced Jun 8, 2026