Stachrom® Heparin

GUDID 03607450009064

DIAGNOSTICA STAGO

Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic

• Primary Device ID: 03607450009064
• NIH Device Record Key: 1d68cd7c-84a9-43bf-8114-9d229aec163d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stachrom® Heparin
• Version Model Number: 00906
• Company DUNS: 262277122
• Company Name: DIAGNOSTICA STAGO
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
• 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	03607450009064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925433

FDA Product Code

• KFF: ASSAY, HEPARIN

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: 2021-04-15
• Device Publish Date: 2016-09-15

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