HemosIL Thrombin Time 00009758515

GUDID 08426950058366

HemosIL Thrombin Time

INSTRUMENTATION LABORATORY COMPANY

Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting

• Primary Device ID: 08426950058366
• NIH Device Record Key: 804b7039-88fb-448a-8f9e-9539a5a43ff1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL Thrombin Time
• Version Model Number: 00009758515
• Catalog Number: 00009758515
• 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@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950058366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862301

FDA Product Code

• GJA: TEST, THROMBIN TIME

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: 2021-07-08
• Device Publish Date: 2016-09-23

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