Pancreatic Elastase CLIA Re-Calibrator and Control Set

FDA UDI

Class I (US FDA UDI)

by American Laboratory Products Company

Identity

Trade Name: Pancreatic Elastase CLIA Re-Calibrator and Control Set FDA UDI
Generic Name: Pancreatic elastase (PE) IVD, calibrator FDA UDI
Device Name: The Pancreatic Elastase CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Pancreatic Elastase CLIA kit (80-PANHU-FC100 or 80-PANHU-FC900) by trained laboratory personnel. For in vitro diagnostic use in the United States. FDA UDI
Model / Reference: 80-PANHU-FCSET FDA UDI
Description: The Pancreatic Elastase CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Pancreatic Elastase CLIA kit (80-PANHU-FC100 or 80-PANHU-FC900) by trained laboratory personnel. For in vitro diagnostic use in the United States. FDA UDI

Identifiers

Primary DI / UDI-DI: B24280PANHUFCSET0 FDA UDI
FDA Product Code: JNN FDA UDI
GMDN Term: Pancreatic elastase (PE) IVD, calibrator 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Pancreatic elastase (PE) IVD, control Pancreatic elastase (PE) IVD, calibrator

Pancreatic Elastase CLIA Re-Calibrator and Control Set by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Pancreatic elastase (PE) IVD, calibrator.

BÜHLMANN fPELA® turbo Calibrator Kit — Bühlmann Laboratories AG

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 14ad916c-21ed-4e22-ad9b-1755423d7f95 34 fields · synced Jun 7, 2026