F.S. Test

GUDID 03607450008579

DIAGNOSTICA STAGO

Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, agglutination, rapid Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical

• Primary Device ID: 03607450008579
• NIH Device Record Key: feeba9b6-6d76-4ca5-a0d3-32e2704b307e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F.S. Test
• Version Model Number: 00857
• 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
• 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	03607450008579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854015

FDA Product Code

• JBN: Fibrin monomer paracoagulation

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

Devices Manufactured by DIAGNOSTICA STAGO

• 03607450581041 - STA Satellite®: 2022-09-16
• 03607450589788 - STA-R Evolution® Expert Series: 2022-09-16
• 03607450589795 - STA-R Evolution® Expert Series (with cap piercing option): 2022-09-16
• 03607450589894 - STA Compact Max® (with cap piercing option): 2022-09-16
• 03607450589900 - STA Compact Max®: 2022-09-16
• 03607450590104 - STA R Max® (with cap piercing option): 2022-09-16
• 03607450590135 - STA R Max®: 2022-09-16
• 03607450590265 - STA R Max®: 2022-09-16