Identity
- Trade Name
- ALPCO C-peptide ELISA Jumbo FDA UDI
- Generic Name
- C-peptide IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ALPCO C-peptide ELISA Jumbo is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 80-CPTHU-E10 FDA UDI
- Description
- The ALPCO C-peptide ELISA Jumbo is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 80-CPTHU-E10 FDA UDI
- Primary DI / UDI-DI
- B24280CPTHUE100 FDA UDI
- FDA Product Code
- JKD FDA UDI
- GMDN Term
- C-peptide IVD, kit, enzyme immunoassay (EIA) 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
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
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, enzyme immunoassay (EIA)
ALPCO C-peptide ELISA Jumbo by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as C-peptide IVD, kit, enzyme immunoassay (EIA).
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- C-PEP-EASIA — Diasource Immunoassays, S.A. · Class I
- C-Peptide AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class I
- Mercodia Ultrasensitive C-peptide ELISA — Mercodia AB · Class I
- ALPCO C-peptide ELISA — American Laboratory Products Company · 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
- American Laboratory Products Company
Sources (1)
- FDA UDI ed977d81-26eb-4004-bfa7-8607135cf525 36 fields · synced May 29, 2026