RAMP® 200 TM Test Module

GUDID 10627966005244

Response Biomedical Corp

Fluorescent immunoassay analyser IVD, point-of-care

• Primary Device ID: 10627966005244
• NIH Device Record Key: a317146e-8aef-4e88-920c-5b41a0e1b3ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAMP® 200 TM Test Module
• Version Model Number: C3100
• Company DUNS: 248609018
• Company Name: Response Biomedical Corp
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10627966005244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071591

FDA Product Code

• KHO: Fluorometer, For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-06-19
• Device Publish Date: 2017-08-31

Devices Manufactured by Response Biomedical Corp

• 10627966005237 - RAMP® 200 CM Control Module: 2023-06-19
• 10627966005244 - RAMP® 200 TM Test Module: 2023-06-19
• 10627966005244 - RAMP® 200 TM Test Module: 2023-06-19
• 10627966005008 - RAMP® Troponin I TEST KIT; 25 TESTS: 2022-06-10
• 10627966005015 - RAMP® CK-MB TEST KIT; 25 TESTS: 2022-06-10
• 10627966005022 - RAMP® Myoglobin TEST KIT; 25 TESTS: 2022-06-10
• 10627966005046 - RAMP® NT-proBNP TEST KIT; 25 TESTS: 2022-06-10
• 10627966005084 - RAMP® CARDIAC CONTROLS; LEVEL 2: 2020-06-30
• 10627966005091 - RAMP® CARDIAC CONTROLS; LEVEL 3: 2020-06-30