Seracult Plus Patient Kit Fecal Occult Blood Test

GUDID 70818087013061

Seracult Plus Patient Kit Fecal Occult Blood Test

PROPPER MANUFACTURING COMPANY, INC.

Faecal occult blood IVD, reagent

• Primary Device ID: 70818087013061
• NIH Device Record Key: 8c87fe11-9bda-4cf0-b71f-54cc5dd39455
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seracult Plus Patient Kit Fecal Occult Blood Test
• Version Model Number: 37500300
• Company DUNS: 001483130
• Company Name: PROPPER MANUFACTURING COMPANY, INC.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	10818087013069 [Unit of Use]
GS1	70818087013061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921798

FDA Product Code

• KHE: Reagent, Occult Blood

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: 2019-03-15
• Device Publish Date: 2019-03-07

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