HemosIL D-Dimer HS 500 00020500100

GUDID 08426950485605

HemosIL D-Dimer HS 500

INSTRUMENTATION LABORATORY COMPANY

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• Primary Device ID: 08426950485605
• NIH Device Record Key: 1c777e49-55cb-40bb-8526-576ff6fab533
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL D-Dimer HS 500
• Version Model Number: 00020500100
• Catalog Number: 00020500100
• 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
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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
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator 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 and calibrator are stable until the expiration date shown on the vial when stored at 2-8°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950485605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090264

FDA Product Code

• DAP: FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, 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 HS 500]

• 08426951391615: HemosIL D-Dimer HS 500 (XL)
• 08426950485605: HemosIL D-Dimer HS 500