HemosIL AcuStar Anti-B2GPI Domain 1 00009800015

GUDID 08426951298778

1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 00009800016 2. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017): 4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018):

INSTRUMENTATION LABORATORY COMPANY

Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 08426951298778
• NIH Device Record Key: 52b09778-563a-488c-838e-3652e8a29779
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL AcuStar Anti-B2GPI Domain 1
• Version Model Number: 00009800015
• Catalog Number: 00009800015
• 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: true
• 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
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426951298778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152875

FDA Product Code

• MSV: System,test,antibodies,b2 - glycoprotein i (b2 - gpi)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-08
• Device Publish Date: 2018-07-17

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• 00195226000542 - ACL TOP 770s: 2024-05-23 ACL TOP 770s
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