PTT-LA

GUDID 13607450005995

DIAGNOSTICA STAGO

Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting

• Primary Device ID: 13607450005995
• NIH Device Record Key: 7da0872e-e1aa-4f8e-9114-785dbeb433b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTT-LA
• Version Model Number: 00599
• 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	03607450005998 [Unit of Use]
GS1	13607450005995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921684

FDA Product Code

• GGW: TEST, TIME, PARTIAL THROMBOPLASTIN

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

On-Brand Devices [PTT-LA]

• 13607450005995: 00599
• 03607450012620: 00599US