directCHECK ACT-LR Whole Blood Control, Level 2 000DCGLR-2

GUDID 00711234170376

directCHECK GH100 ACTLR2 15/box

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control

• Primary Device ID: 00711234170376
• NIH Device Record Key: 0369dae1-9c49-4775-a47f-d3c2e86382c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: directCHECK ACT-LR Whole Blood Control, Level 2
• Version Model Number: 000DCGLR-2
• Catalog Number: 000DCGLR-2
• Company DUNS: 079299318
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Device Count: 15
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00711234170376 [Unit of Use]
GS1	10711234170373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202101

FDA Product Code

• GGN: Plasma, Coagulation Control

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-21

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