Identity
- Trade Name
- ALPCO Pancreatic Elastase CLIA FDA UDI
- Generic Name
- Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for the quantitative measurement of fecal pancreatic elastase (PE) in human stool. The Pancreatic Elastase CLIA kit is intended for in vitro diagnostic use as an aid in the diagnosis and treatment of pancreatic disease, including exocrine pancreatic insufficiency (EPI), in conjunction with other clinical and laboratory findings. The test is specifically designed for use with the KleeYa platform. For In Vitro Diagnostic Use in the United States. FDA UDI
- Model / Reference
- 80-PANHU-FC100 FDA UDI
- Description
- The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for the quantitative measurement of fecal pancreatic elastase (PE) in human stool. The Pancreatic Elastase CLIA kit is intended for in vitro diagnostic use as an aid in the diagnosis and treatment of pancreatic disease, including exocrine pancreatic insufficiency (EPI), in conjunction with other clinical and laboratory findings. The test is specifically designed for use with the KleeYa platform. For In Vitro Diagnostic Use in the United States. FDA UDI
Identifiers
- Catalog Number
- 80-PANHU-FC100 FDA UDI
- Primary DI / UDI-DI
- B24280PANHUFC1000 FDA UDI
- FDA Product Code
- JNN FDA UDI
- GMDN Term
- Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1725 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: Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)
ALPCO Pancreatic Elastase CLIA by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA).
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- Pancreatic Elastase ELISA — Seramun Diagnostica GmbH
- Pancreatic Elastase ELISA — Seramun Diagnostica GmbH · Class I
- Pancreatic Elastase Chemiluminescence ELISA — American Laboratory Products Company · Class I
- Pancreatic Elastase 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 903fe5a6-8bc0-4762-98fb-c0d1eb83f398 36 fields · synced Jun 8, 2026