STA® - Deficient II

GUDID 13607450007456

DIAGNOSTICA STAGO

Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting Coagulation factor II (prothrombin) IVD, kit, clotting

• Primary Device ID: 13607450007456
• NIH Device Record Key: b230e0c4-cfe0-4bbf-bcb5-09f29a200692
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STA® - Deficient II
• Version Model Number: 00745
• Company DUNS: 262277122
• Company Name: DIAGNOSTICA STAGO
• Device Count: 6
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607450007459 [Unit of Use]
GS1	13607450007456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934606

FDA Product Code

• GJS: TEST, TIME, PROTHROMBIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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