ANA/HEp-2 IgG IFA 96 Test

GUDID G5229023441

For the detection and titration of anti-nuclear IgG antibodies in human sera

Hemagen Diagnostics, Inc.

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

• Primary Device ID: G5229023441
• NIH Device Record Key: 77972f02-22e1-4059-97e3-9c361b61373f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANA/HEp-2 IgG IFA 96 Test
• Version Model Number: 902344
• Company DUNS: 147827216
• Company Name: Hemagen 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: true
• 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: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.com
• Phone: 443 367 5500
• Email: customerservice@hemagen.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
• 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
HIBCC	G5229023441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K841127

FDA Product Code

• DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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: 2023-10-13
• Device Publish Date: 2023-10-05

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