Chromogenic Optic 00009757950

GUDID 08426950452775

HemosIL Chromogenic Optic Test Kit

INSTRUMENTATION LABORATORY COMPANY

Optical instrument performance standard calibrator/control IVD, single-use

• Primary Device ID: 08426950452775
• NIH Device Record Key: be79cde8-a00d-41ee-b6f3-ad76cb9e9a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chromogenic Optic
• Version Model Number: 00009757950
• Catalog Number: 00009757950
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 800-678-0710
• Email: techsupport@ilww.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950452775 [Primary]

FDA Product Code

• JPA: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-10-10
• Device Publish Date: 2016-09-23

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• 08430793243001 - HEMOSIL RIVAROXABAN CALIBRATORS: 2024-07-30 1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vi
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• 00195226000528 - ACL TOP 770: 2024-05-23 ACL TOP 770
• 00195226000535 - ACL TOP 770 LAS: 2024-05-23 ACL TOP 770 LAS
• 00195226000542 - ACL TOP 770s: 2024-05-23 ACL TOP 770s
• 00195226000559 - ACL TOP 570: 2024-05-23 ACL TOP 570
• 00195226000566 - ACL TOP 370: 2024-05-23 ACL TOP 370