RAMP® Troponin I TEST KIT; 25 TESTS

GUDID 10627966005008

Response Biomedical Corp

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• Primary Device ID: 10627966005008
• NIH Device Record Key: 4b1b8469-df95-452b-961c-4411ff621206
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAMP® Troponin I TEST KIT; 25 TESTS
• Version Model Number: C1101
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10627966005008 [Primary]

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: 2022-06-10
• Device Publish Date: 2016-09-05

Devices Manufactured by Response Biomedical Corp

• 10627966005237 - RAMP® 200 CM Control Module: 2023-06-19
• 10627966005244 - RAMP® 200 TM Test Module: 2023-06-19
• 10627966005008 - RAMP® Troponin I TEST KIT; 25 TESTS: 2022-06-10
• 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