Stool Preparation Set

GUDID 04099466400116

Seramun Diagnostica GmbH

Pancreatic elastase (PE) IVD, reagent

• Primary Device ID: 04099466400116
• NIH Device Record Key: ff30c6fb-4b1d-4741-b259-de186ff5387b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stool Preparation Set
• Version Model Number: ACS-001
• Company DUNS: 344006309
• Company Name: Seramun Diagnostica GmbH
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04099466400116 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 2024-11-29
• Device Publish Date: 2024-11-21

Devices Manufactured by Seramun Diagnostica GmbH

• 04099466112248 - Pancreatic Elastase ELISA: 2024-11-29
• 04099466400116 - Stool Preparation Set: 2024-11-29
• 04099466400116 - Stool Preparation Set: 2024-11-29
• 04099466112231 - Pancreatic Elastase ELISA: 2023-10-09