ScheBo® Pancreatic Elastase 1™ 07

GUDID 04260152080701

ScheBo r. Biotech Aktiengesellschaft

Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04260152080701
• NIH Device Record Key: 82b5359b-2d66-49f7-b254-48c6bcabb7c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScheBo® Pancreatic Elastase 1™
• Version Model Number: ELISA Stool Test
• Catalog Number: 07
• Company DUNS: 326980364
• Company Name: ScheBo r. Biotech Aktiengesellschaft
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260152080701 [Primary]

FDA Product Code

• JNN: P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-07
• Device Publish Date: 2020-08-30

Devices Manufactured by ScheBo r. Biotech Aktiengesellschaft

• 04260152082804 - ScheBo Master Quick-Prep: 2023-06-20
• 04260152080206 - ScheBo® Extraction buffer: 2020-09-07
• 04260152080701 - ScheBo® Pancreatic Elastase 1™: 2020-09-07
• 04260152080701 - ScheBo® Pancreatic Elastase 1™: 2020-09-07