HemosIL D-Dimer Controls 00020008610

GUDID 08426950063179

HemosIL D-Dimer Controls

INSTRUMENTATION LABORATORY COMPANY

D-dimer IVD, control

• Primary Device ID: 08426950063179
• NIH Device Record Key: 1c03c6fe-71fc-4f94-93cb-049babd26e2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL D-Dimer Controls
• Version Model Number: 00020008610
• Catalog Number: 00020008610
• 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: 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
• Phone: 18006780710
• Email: techsupport.na@werfen.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Unopened controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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 controls 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	08426950063179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070927

FDA Product Code

• GGN: PLASMA, COAGULATION CONTROL

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

On-Brand Devices [HemosIL D-Dimer Controls]

• 08426950063179: HemosIL D-Dimer Controls
• 00195226000511: 1. Level 1 D-D Control(Cat. No. 0022660031): 5 vials x 1 mL 2. Level 2 D-D Control(Cat. No. 0022