cobas PCR Media 08261598190

GUDID 00875197006216

Roche Molecular Systems, Inc.

General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen transport medium collection kit, non-sterile General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium

• Primary Device ID: 00875197006216
• NIH Device Record Key: a5c84b67-55e9-4ef7-8a00-48c1dd3f86a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas PCR Media
• Version Model Number: 08261598190
• Catalog Number: 08261598190
• Company DUNS: 071674100
• Company Name: Roche Molecular Systems, Inc.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197006216 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

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: 2020-07-09
• Device Publish Date: 2020-07-01

Devices Manufactured by Roche Molecular Systems, Inc.

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• 04015630929009 - cobas x 480 Analyzer: 2022-06-10
• 00875197006391 - cobas® HCV: 2021-12-22
• 00875197006407 - cobas® HIV-1: 2021-12-22
• 00875197006414 - cobas® HBV: 2021-12-22
• 00875197006421 - cobas® CMV: 2021-12-22