cobas¿ HBVHCVHIV1 Control Kit 06998887190

GUDID 00875197004748

Roche Diagnostics GmbH

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

• Primary Device ID: 00875197004748
• NIH Device Record Key: efc546ca-bb8a-4308-9819-28cc1981a504
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas¿ HBVHCVHIV1 Control Kit
• Version Model Number: 1.0
• Catalog Number: 06998887190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197004748 [Primary]

FDA Product Code

• MZP: ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

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: 2015-12-04

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