FDP Plasma

GUDID 03607450005400

DIAGNOSTICA STAGO

Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination

• Primary Device ID: 03607450005400
• NIH Device Record Key: 9a7cfab7-6d31-400f-9727-812fd9b2cd0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDP Plasma
• Version Model Number: 00540
• 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	03607450005400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920943

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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