Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- C-peptide IVD, control FDA UDI
- Device Name
- ARCHITECT C-Peptide Controls FDA UDI
- Model / Reference
- 03L5311 FDA UDI
- Description
- ARCHITECT C-Peptide Controls FDA UDI
Identifiers
- Catalog Number
- 03L5311 FDA UDI
- Primary DI / UDI-DI
- 00380740156008 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- C-peptide IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: C-peptide IVD, control
Architect by Abbott — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-peptide IVD, control.
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- IMMULITE® Systems CPE CONTROL C-Peptide — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- Atellica IM CpS MCM — Siemens Healthcare Diagnostics · Class I
- AIA-PACK C-Peptide Control Set — Tosoh Corp. · Class I
- Alinity — Abbott · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA UDI f8f995bb-3ed8-4660-81bb-d7d2637f141b 36 fields · synced Jun 1, 2026