Asserachrom® D-Di

GUDID 03607450009477

DIAGNOSTICA STAGO

D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03607450009477
• NIH Device Record Key: 39140ace-225f-4e9b-8de2-d3862f13b489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Asserachrom® D-Di
• Version Model Number: 00947
• 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	03607450009477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862156

FDA Product Code

• DAP: FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, 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: 2021-05-03
• Device Publish Date: 2016-09-15

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