Precinorm U plus 12149435160

GUDID 04015630936380

Roche Diagnostics GmbH

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 04015630936380
• NIH Device Record Key: 62605142-d347-4b1f-9d3e-d7f406484724
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precinorm U plus
• Version Model Number: 12149435160
• Catalog Number: 12149435160
• 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	04015630936380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042389

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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

• 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
• 04015630939114 - Elecsys BRAHMS PCT: 2026-02-09
• 04015630940073 - Elecsys BRAHMS PCT: 2026-02-09
• 07613336224281 - PreciControl Rubella IgG: 2026-02-05