Elecsys Myoglobin Immunoassay 12178214160

GUDID 04015630939060

Roche Diagnostics GmbH

Myoglobin IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630939060
• NIH Device Record Key: fe95078e-c430-4e11-836f-8e5f1b40e5f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Myoglobin Immunoassay
• Version Model Number: 12178214160
• Catalog Number: 12178214160
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630939060 [Primary]

FDA Product Code

• DDR: MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2026-02-23
• Device Publish Date: 2016-09-20

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
• 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