AccessGUDID - DEVICE: ALPCO Pancreatic Elastase CLIA (B24280PANHUFC1000)

GUDID

Device Identifier (DI) Information

Brand Name: ALPCO Pancreatic Elastase CLIA
Version or Model: 80-PANHU-FC100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80-PANHU-FC100
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24280PANHUFC1000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53142	Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of pancreatic elastase (PE) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of conditions associated with pancreatic insufficiency (e.g., chronic pancreatitis).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JNN	P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 903fe5a6-8bc0-4762-98fb-c0d1eb83f398
Public Version Date: November 07, 2024
Public Version Number: 2
DI Record Publish Date: July 25, 2024