EXACTA GLANCE

GUDID 00365702701274

CONTROL SOLUTIONS LEVEL 1 US

Roche Diagnostics Operations, Inc.

Glucose IVD, control

• Primary Device ID: 00365702701274
• NIH Device Record Key: 846edae2-f9c4-4e34-b75f-44c158be4ddd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXACTA GLANCE
• Version Model Number: 09409955001
• Company DUNS: 141608724
• Company Name: Roche Diagnostics Operations, 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365702701274 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2022-09-12
• Device Publish Date: 2022-09-02

On-Brand Devices [EXACTA GLANCE]

• 00365702701489: CONTROL SOLUTION LEVEL 2 US
• 00365702701274: CONTROL SOLUTIONS LEVEL 1 US