Rapid Cartridge B (iRapidB) 09511741190

GUDID 07613336228647

Roche Diagnostics GmbH

High performance liquid chromatography analyser column IVD

• Primary Device ID: 07613336228647
• NIH Device Record Key: 150f6181-102a-4f37-a2ed-2a8aa8d2bd0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid Cartridge B (iRapidB)
• Version Model Number: 09511741190
• Catalog Number: 09511741190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	07613336228647 [Primary]

FDA Product Code

• DPM: COLUMNS, LIQUID CHROMATOGRAPHY

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: 2025-08-08
• Device Publish Date: 2025-07-31

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• 07613336228647 - Rapid Cartridge B (iRapidB): 2025-08-08
• 07613336228647 - Rapid Cartridge B (iRapidB): 2025-08-08
• 07613336228654 - Rapid Cartridge C (iRapidC): 2025-08-08
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• 07613336179451 - Anti-SARS-CoV-2: 2025-07-30
• 07613336180167 - PreciControl Anti-SARS-CoV-2: 2025-07-30