HemosIL Liquid Anti-Xa 0020303600

GUDID 00195226000054

HemosIL Liquid Anti-Xa 1. Factor Xa Reagent (0020303610) 5 x 5mL 2. Chromogenic substrate (0020303620) 5 x 6mL

INSTRUMENTATION LABORATORY COMPANY

Coagulation factor Xa inhibitor IVD, kit, clotting

• Primary Device ID: 00195226000054
• NIH Device Record Key: 04a8b52c-235b-438e-9574-8d76ef375c1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL Liquid Anti-Xa
• Version Model Number: 0020303600
• Catalog Number: 0020303600
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• 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: 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: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
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• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@ilww.com
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• Email: techsupport@werfen.com
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• Phone: 1-800-678-0710
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• Phone: 1-800-678-0710
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• Email: techsupport.na@werfen.com
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• Phone: 1-800-678-0710
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• Phone: 1-800-678-0710
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• Phone: 1-800-678-0710
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• Phone: 1-800-678-0710
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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
• 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
• 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
• 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
• 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	00195226000054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190032

FDA Product Code

• QLU: Anti-Factor Xa Activity Test System, Apixaban

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: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [HemosIL Liquid Anti-Xa]

• 00195226000054: HemosIL Liquid Anti-Xa 1. Factor Xa Reagent (0020303610) 5 x 5mL 2. Chromogenic substrate (00203
• 00195226000016: HemosIL Liquid Anti-Xa 1. Factor Xa Reagent (0020302612) 5 x 2.5 mL 2. Chromogenic substrate (0
• 08426950580324: HemosIL Liquid Anti-Xa