Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Complement components C3/C3c IVD, reagent FDA UDI
- Device Name
- CLIN CHEM C3 REAGENT FDA UDI
- Model / Reference
- 9D96-21 FDA UDI
- Description
- CLIN CHEM C3 REAGENT FDA UDI
Identifiers
- Catalog Number
- 09D9621 FDA UDI
- Primary DI / UDI-DI
- 00380740019730 FDA UDI
- FDA Product Code
- CZW FDA UDI
- GMDN Term
- Complement components C3/C3c IVD, reagent 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 components C3/C3c IVD, reagent
Architect by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Complement components C3/C3c IVD, reagent.
- K-ASSAY® Complement C3 Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- IHC — Slmp, LLC · 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
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI b7746237-1dfa-4b58-8139-e16969696d10 36 fields · synced May 30, 2026