Seracult Plus Single Slide Fecal Occult Blood Test

GUDID 70818087013054

Seracult Plus Single Slide Fecal Occult Blood Test

PROPPER MANUFACTURING COMPANY, INC.

Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent

• Primary Device ID: 70818087013054
• NIH Device Record Key: 2e8cfecf-e391-4db3-aa98-6928aa9c1659
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seracult Plus Single Slide Fecal Occult Blood Test
• Version Model Number: 37400200
• Company DUNS: 001483130
• Company Name: PROPPER MANUFACTURING COMPANY, INC.
• Device Count: 1000
• 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	10818087013052 [Unit of Use]
GS1	70818087013054 [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

On-Brand Devices [Seracult Plus Single Slide Fecal Occult Blood Test]

• 70818087013054: Seracult Plus Single Slide Fecal Occult Blood Test
• 30818087013049: Seracult Plus Single Slide Fecal Occult Blood Test