AccessGUDID - DEVICE: IDK® Pancreatic Elastase ELISA (04050598008540)

GUDID

Device Identifier (DI) Information

Brand Name: IDK® Pancreatic Elastase ELISA
Version or Model: K 6915.20.US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Immundiagnostik AG

Primary DI Number: 04050598008540
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 321663841 *Terms of Use

Device Description: No description.

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):	No
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?
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: b91c9d80-c4a4-47e3-a005-16ce53794bdf
Public Version Date: November 07, 2024
Public Version Number: 2
DI Record Publish Date: June 21, 2023