Identity
- Trade Name
- Bordetella pertussis Toxin (PT) IgG ELISA FDA UDI
- Generic Name
- Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin. FDA UDI
- Model / Reference
- EIA-6133 FDA UDI
- Description
- The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin. FDA UDI
Identifiers
- Catalog Number
- EIA-6133 FDA UDI
- Primary DI / UDI-DI
- 04048474061338 FDA UDI
- FDA Product Code
- GOX FDA UDI
- GMDN Term
- Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3065 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
Bordetella pertussis Toxin (PT) IgG ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI 7488c1c2-1f83-4022-9536-068ef19da99f 37 fields · synced May 30, 2026