AccessGUDID - DEVICE: Pancreatic Elastase CLIA Re-Calibrator and Control Set (B24280PANHUFCSET0)

GUDID

Device Identifier (DI) Information

Brand Name: Pancreatic Elastase CLIA Re-Calibrator and Control Set
Version or Model: 80-PANHU-FCSET
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24280PANHUFCSET0
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 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.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
53143	Pancreatic elastase (PE) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of pancreatic elastase (PE) in a clinical specimen.	Active	false
53144	Pancreatic elastase (PE) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of pancreatic elastase (PE) in a clinical specimen.	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: 14ad916c-21ed-4e22-ad9b-1755423d7f95
Public Version Date: June 16, 2025
Public Version Number: 1
DI Record Publish Date: June 06, 2025