STA® - VWF:Ag Calibrator

GUDID 13607450005209

DIAGNOSTICA STAGO

Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator Coagulation factor VIII-associated antigen IVD, calibrator

• Primary Device ID: 13607450005209
• NIH Device Record Key: 559416d7-8aa6-41d4-b2b0-1717e0f63ef3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STA® - VWF:Ag Calibrator
• Version Model Number: 00520
• 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	03607450005202 [Unit of Use]
GS1	13607450005209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962671

FDA Product Code

• GJT: PLASMA, COAGULATION FACTOR DEFICIENT

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