HemosIL AcuStar Anti-Cardiolipin IgG 0009802004

GUDID 08426950496953

HemosIL AcuStar Anti-Cardiolipin IgG

INSTRUMENTATION LABORATORY COMPANY

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08426950496953
• NIH Device Record Key: f851e406-7f98-49e8-8781-1b4f1bb20b0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL AcuStar Anti-Cardiolipin IgG
• Version Model Number: 0009802004
• Catalog Number: 0009802004
• 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
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950496953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092181

FDA Product Code

• MID: SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL

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

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