FOBT-CHEK

GUDID 00816917021539

Positive/Negative Controls for OC-Light and OC-Light S

POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Faecal occult blood IVD, control

• Primary Device ID: 00816917021539
• NIH Device Record Key: 25549813-60c4-4295-b496-62da4ddeec83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOBT-CHEK
• Version Model Number: FBT-POC
• Company DUNS: 078413594
• Company Name: POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
• Device Count: 1
• 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: 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816917021539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041297

FDA Product Code

• KHE: Reagent, Occult Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [FOBT-CHEK]

• 00816917021539: Positive/Negative Controls for OC-Light and OC-Light S
• 00855574005520: Negative Control for OC-Auto
• 00855574005209: Positive Control for OC-Auto
• 00816917025308: Negative Control for OC-Auto for Brazil
• 00816917025292: Positive Control for OC-Auto for Brazil
• 00816917025179: Positive Control for OC-Auto SENSOR io