Identity
- Trade Name
- Antiserum to Human C-4 (b1e) FDA UDI
- Generic Name
- Complement components C4/C4c IVD, antibody FDA UDI
- Device Name
- Goat antiserum to Human C-4 (b1e) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Goat antiserum to Human C-4 (b1e) FDA UDI
Identifiers
- Catalog Number
- 109002 FDA UDI
- Primary DI / UDI-DI
- B1761090 FDA UDI
- FDA Product Code
- DBI FDA UDI
- GMDN Term
- Complement components C4/C4c 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: Complement components C4/C4c IVD, antibody
Antiserum to Human C-4 (b1e) by Kent Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Complement components C4/C4c IVD, antibody.
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- Anti Human Complement C4 (b1e) FITC — KENT LABORATORIES, INC. · Class II
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- C-4 (b1e) RID plate kit — 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
- Kent Laboratories, Inc.
Sources (1)
- FDA UDI 4e79ef76-a437-4a4d-a747-37e71ae93150 34 fields · synced May 31, 2026