Identity
- Trade Name
- IMMULITE® 2000 Systems C-Peptide FDA UDI
- Generic Name
- C-peptide IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- C-Peptide - IMMULITE - RGT - 200 Tests FDA UDI
- Model / Reference
- 10381450 FDA UDI
- Description
- C-Peptide - IMMULITE - RGT - 200 Tests FDA UDI
Identifiers
- Catalog Number
- L2KPEP2 FDA UDI
- Primary DI / UDI-DI
- 00630414961873 FDA UDI
- FDA Product Code
- JKD FDA UDI
- GMDN Term
- C-peptide IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1135 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: C-peptide IVD, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems C-Peptide by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-peptide IVD, kit, chemiluminescent immunoassay.
- STELLUX® Chemi Human C-peptide ELISA Lab Pack — American Laboratory Products Company · Class I
- C-Peptide AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class I
- ARCHITECT — Abbott · Class I
- STELLUX® Chemi Human C-peptide ELISA — American Laboratory Products Company · Class I
- LIAISON® C-PEPTID — Diasorin Inc.
- C-Peptide & Insulin Diabetes Panel AccuLite VAST CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
- C-Peptide ELISA — DRG International, Inc. · Class I
- VITROS — Ortho-Clinical Diagnostics · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 5345bc68-fd12-4c01-a78f-63bcdaf8a62e 36 fields · synced May 29, 2026