IgD|FITC, Polyclonal, GPab
EUDAMEDFDA UDIClass IVD General (EU MDR)
by Bio SB Inc
Identity
- Trade Name
- IgD|FITC, Polyclonal, GPab EUDAMEDIgD / FITC GPab FDA UDI
- Generic Name
- Total immunoglobulin D (IgD total) IVD, antibody FDA UDI
- Device Name
- IgD|FITC, Polyclonal, GPab EUDAMEDThe IgD/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2) FDA UDI
- Model / Reference
- BSB-3006-1 EUDAMEDConcentrate, 1 ml FDA UDI
- Description
- The IgD/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2) FDA UDI
Identifiers
- Catalog Number
- BSB 3006-1 FDA UDI
- Primary DI / UDI-DI
- B502BSB300610 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB300610 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Total immunoglobulin D (IgD total) IVD, antibody FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
IgD|FITC, Polyclonal, GPab is a medical device used in the diagnosis and treatment of autoimmune diseases. It is a monoclonal antibody-based test that detects IgD antibodies in blood samples, providing valuable information for clinicians to make informed decisions.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-B502BSB300610 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Bio SB Inc
- EUDAMED SRN
- US-MF-000036462
- Authorised Representative
- QAdvis EAR AB SE-AR-000001599
Sources (2)
- EUDAMED 089e2c9a-aff6-4ab1-9145-8d75b3c6c6f0 61 fields · synced Jul 21, 2026
- FDA UDI 20723d23-acf5-4488-b8a6-5fb5169c55c1 34 fields · synced May 30, 2026