HemosIL AcuStar Anti-B2GPI Domain 1 Controls 00009800022

GUDID 08426951301706

1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.

INSTRUMENTATION LABORATORY COMPANY

Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control Beta-2-glycoprotein I antibody IVD, control

• Primary Device ID: 08426951301706
• NIH Device Record Key: 6aec0b80-174d-4adc-a0f8-c47e9d0c1579
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL AcuStar Anti-B2GPI Domain 1 Controls
• Version Model Number: 00009800022
• Catalog Number: 00009800022
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Device Count: 6
• 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@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

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426951301706 [Primary]
GS1	18426951301703 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152875

FDA Product Code

• JJX: Single (specified) analyte controls (assayed and unassayed)

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: 2021-07-12
• Device Publish Date: 2018-07-17

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

• 00195226000641 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests): 2023-10-11 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 T
• 00195226000627 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (600 T
• 00195226000634 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 T
• 00195226000658 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (150 T
• 00195226000665 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (75 Te
• 00195226000672 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2
• 00195226000689 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2
• 00195226000696 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2