OC-Light S

GUDID 00816917022949

Personal Use Kit OC-Light S, Custom Kit for Alameda Health System

POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00816917022949
• NIH Device Record Key: f486692b-c34f-4869-8f6f-704f37ab81da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OC-Light S
• Version Model Number: FBPUS-ALAM
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816917022949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143325

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: 2018-10-24
• Device Publish Date: 2018-09-23

On-Brand Devices [OC-Light S]

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• 00816917022949: Personal Use Kit OC-Light S, Custom Kit for Alameda Health System
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