cobas Liat Strep A Script Version 1.27 08403856001

GUDID 07613336156544

Roche Molecular Systems, Inc.

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 07613336156544
• NIH Device Record Key: 9224fe76-cdff-4741-a14e-c7dad2c74f80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas Liat Strep A Script Version 1.27
• Version Model Number: 08403856001
• Catalog Number: 08403856001
• Company DUNS: 071674100
• Company Name: Roche Molecular Systems, Inc.
• 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: 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	07613336156544 [Primary]

FDA Product Code

• PGX: Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-17

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• 00875197006407 - cobas® HIV-1: 2021-12-22
• 00875197006414 - cobas® HBV: 2021-12-22
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