HemosIL Q.F.A. Thrombin (Bovine) - 2 mL 00020301800

GUDID 08426950573500

HemosIL Q.F.A. Thrombin (Bovine) - 2 mL

INSTRUMENTATION LABORATORY COMPANY

Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting

• Primary Device ID: 08426950573500
• NIH Device Record Key: 21c8ac08-6592-43e1-a67e-d51532986355
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL Q.F.A. Thrombin (Bovine) - 2 mL
• Version Model Number: 00020301800
• Catalog Number: 00020301800
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Device Count: 10
• DM Exempt: false
• 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: 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: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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 reagent is 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	08426950573500 [Primary]
GS1	18426950573507 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963902

FDA Product Code

• GIS: TEST, FIBRINOGEN

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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