STA® - Liquid Anti-Xa 8

GUDID 03607450011791

DIAGNOSTICA STAGO

Heparin anti-Xa IVD, kit, chromogenic

• Primary Device ID: 03607450011791
• NIH Device Record Key: 05a46ced-8a37-4c16-a040-509895323e5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STA® - Liquid Anti-Xa 8
• Version Model Number: 00322US
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607450011791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111822

FDA Product Code

• KFF: ASSAY, HEPARIN

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: 2021-04-23
• 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