HemosIL AcuStar HIT-IgG (PF4-H) 00009800127

GUDID 08426951126545

1. HIT- IgG(PF4-H)Cartridges for 25 determinations (Cat No 0009800128) 2. HIT-IgG (PF4-H) Calibaratior 1 (Cat No 0009800129) 3. HIT-IgG (PF4-H) Calibaratior 2 (Cat No 0009800130)

INSTRUMENTATION LABORATORY COMPANY

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08426951126545
• NIH Device Record Key: f15d49df-94ef-47d5-a5b1-07ff103d6f40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL AcuStar HIT-IgG (PF4-H)
• Version Model Number: 0009800127
• Catalog Number: 00009800127
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *1. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426951126545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170854

FDA Product Code

• LCO: PLATELET FACTOR 4 RADIOIMMUNOASSAY

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: 2018-07-12

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