Identity
- Trade Name
- STELLUX® Chemi Human Total Proinsulin ELISA FDA UDI
- Generic Name
- Proinsulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Proinsulin (Total) Chemiluminescence ELISA is designed for the quantitative determination of proinsulin in human serum, plasma (EDTA and heparin), and tissue culture supernatants. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 80-PINHUT-CH01 FDA UDI
- Description
- The Proinsulin (Total) Chemiluminescence ELISA is designed for the quantitative determination of proinsulin in human serum, plasma (EDTA and heparin), and tissue culture supernatants. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 80-PINHUT-CH01 FDA UDI
- Primary DI / UDI-DI
- B24280PINHUTCH010 FDA UDI
- FDA Product Code
- JKD FDA UDI
- GMDN Term
- Proinsulin 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: Proinsulin IVD, kit, enzyme immunoassay (EIA)
STELLUX® Chemi Human Total Proinsulin ELISA by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 8196bdcd-56b7-4a79-9cbf-ab5e95f5cd20 36 fields · synced May 30, 2026