Identity
- Trade Name
- STELLUX® Chemi Human Insulin ELISA Jumbo FDA UDI
- Generic Name
- Insulin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- The ALPCO Insulin Chemiluminescence ELISA Jumbo is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 80-INSHU-CH10 FDA UDI
- Description
- The ALPCO Insulin Chemiluminescence ELISA Jumbo is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 80-INSHU-CH10 FDA UDI
- Primary DI / UDI-DI
- B24280INSHUCH100 FDA UDI
- FDA Product Code
- CFP FDA UDI
- GMDN Term
- Insulin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1405 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: Insulin IVD, kit, chemiluminescent immunoassay
STELLUX® Chemi Human Insulin ELISA Jumbo by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin IVD, kit, chemiluminescent immunoassay.
- Insulin AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
- LIAISON® Insulin — Diasorin Inc.
- iFlash-Insulin — Shenzhen YHLO Biotech Co., Ltd. · Class I
- IMMULITE® 2000 Systems INS Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Atellica IM IRI — Siemens Healthcare Diagnostics · Class I
- Elecsys Insulin — Roche Diagnostics Corp. · Class I
- Insulin AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class I
- IMMULITE® 2000 Systems INS Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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
- American Laboratory Products Company
Sources (1)
- FDA UDI 717e90be-cecf-40e6-ba2e-84d91e620604 36 fields · synced May 29, 2026