ISE Internal Standard Gen.2 conc. 09137742190

GUDID 07613336222331

Roche Diagnostics GmbH

Multiple-type clinical chemistry analyte profile IVD, calibrator

• Primary Device ID: 07613336222331
• NIH Device Record Key: 35d610b4-6953-451e-998d-9e38a1ff52a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Internal Standard Gen.2 conc.
• Version Model Number: 09137742190
• Catalog Number: 09137742190
• 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: true
• 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	07613336222331 [Primary]

FDA Product Code

• JIT: Calibrator, secondary

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: 2026-03-30
• Device Publish Date: 2026-03-20

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• 04015630911707 - Elecsys Myoglobin STAT CalSet: 2026-02-23
• 04015630918805 - Cfas PUC: 2026-02-23