Control Set DAT I 3312950190

GUDID 04015630996599

Roche Diagnostics GmbH

Multiple therapeutic drugs/drugs of abuse IVD, control

• Primary Device ID: 04015630996599
• NIH Device Record Key: 90c6daea-d6a4-4f80-821c-896fa5768395
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Set DAT I
• Version Model Number: 3312950190
• Catalog Number: 3312950190
• 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: true
• 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	04015630996599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080183

FDA Product Code

• DIF: Drug mixture control materials

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: 2021-01-26
• Device Publish Date: 2021-01-18

Devices Manufactured by Roche Diagnostics GmbH

• 04015630926091 - Testosterone II CalSet II: 2026-03-03
• 07613336218402 - Elecsys LH: 2026-02-27
• 07613336236499 - Elecsys BRAHMS PCT: 2026-02-27
• 04015630911707 - Elecsys Myoglobin STAT CalSet: 2026-02-23
• 04015630918805 - Cfas PUC: 2026-02-23
• 04015630919932 - C.f.a.s. PAC: 2026-02-23
• 04015630936373 - Cfas Proteins: 2026-02-23
• 04015630939060 - Elecsys Myoglobin Immunoassay: 2026-02-23