ANA IFA: HEp-20-10

GUDID 04049016045359

EUROIMMUN Medizinische Labordiagnostika AG

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

• Primary Device ID: 04049016045359
• NIH Device Record Key: 436b5590-88e1-4431-8ae7-4d0a33f429ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANA IFA: HEp-20-10
• Version Model Number: FA 1522-1010
• Company DUNS: 322209263
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016045359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070763

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [ANA IFA: HEp-20-10]

• 04049016045403: FA 1522-2010
• 04049016045397: FA 1522-2005
• 04049016045380: FA 1522-2003
• 04049016045366: FA 1522-1050
• 04049016045359: FA 1522-1010
• 04049016045342: FA 1522-1005
• 04049016045335: FA 1522-1003