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Human Complement C1q BINDARID™ Radial Immunodiffusion Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Human Complement C1q BINDARID™ Radial Immunodiffusion Kit FDA UDI
- Generic Name
- Complement component C1q IVD, antibody FDA UDI
- Model / Reference
- RN020.3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700010511 FDA UDI
- 510(k) Number
- K914388 FDA UDI
- FDA Product Code
- DAK FDA UDI
- GMDN Term
- Complement component C1q IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5240 FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Complement component C1q IVD, antibody
Human Complement C1q BINDARID™ Radial Immunodiffusion Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Complement component C1q IVD, antibody.
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- Antiserum to Human C1q — KENT LABORATORIES, INC. · Class II
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- Anti Human Complement C1q FITC — KENT LABORATORIES, INC. · Class II
- C1q RID plate package — KENT LABORATORIES, INC. · Class I
- C1q RID plate package — KENT LABORATORIES, INC. · Class I
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
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI 379fefca-a406-426e-93a5-5b6e6e72bed3 35 fields · synced May 31, 2026