Identity
- Trade Name
- Complement Activation (CAE) Reagent Set FDA UDI
- Generic Name
- Total complement activity (CH50) IVD, reagent FDA UDI
- Model / Reference
- 6100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056771600798 FDA UDI
- GMDN Term
- Total complement activity (CH50) IVD, reagent FDA UDI
Classification
- 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
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: Total complement activity (CH50) IVD, reagent
Complement Activation (CAE) Reagent Set by Diasorin Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total complement activity (CH50) IVD, reagent.
- Optilite® CH50 Reagent — The Binding Site Group · Class II
- Autokit CH50 — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class II
- CH50 Calibrator — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Diasorin Inc.
Sources (1)
- FDA UDI 443888b4-8c8f-4dde-98e3-fea9563c536d 33 fields · synced May 30, 2026