Aptiva® APS IgM Calibrators

GUDID 08430793040907

1.Aptiva APS IgM Calibrator 1 (2x0.3mL) 2. Aptiva APS IgM Calibrator 2 (2x0.3mL) 3. Aptiva APS IgM Calibrator 3 (2x0.3mL)

INOVA DIAGNOSTICS, INC.

Anticardiolipin antibody IVD, calibrator

• Primary Device ID: 08430793040907
• NIH Device Record Key: b12ad46f-2cec-40ca-9d1e-f3c8dbb0ea6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aptiva® APS IgM Calibrators
• Version Model Number: 725141
• Company DUNS: 188354831
• Company Name: INOVA DIAGNOSTICS, INC.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08430793040907 [Primary]

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-19
• Device Publish Date: 2024-03-11

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