Anti-HSV-2 (gG2) ELISA (IgG)

GUDID 04049016096733

EUROIMMUN Medizinische Labordiagnostika AG

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04049016096733
• NIH Device Record Key: 562cc5b2-159a-4abe-a35e-30adff2a9a36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-HSV-2 (gG2) ELISA (IgG)
• Version Model Number: EI 2532-9601-24 G
• 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
• 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	04049016096733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061239

FDA Product Code

• MYF: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

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

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

• 04049016139232 - Free Triiodothyronine (FT3) ELISA: 2025-09-22
• 04049016151982 - Mounting medium (IIFT): 2025-07-11
• 04049016152002 - Mounting medium (IIFT): 2025-07-11
• 04049016151791 - ELISA sample buffer: 2025-07-10
• 04049016151838 - ELISA chromogen/substrate solution: 2025-07-10
• 04049016151845 - ELISA Stop solution: 2025-07-04
• 04049016137986 - EUROLabWorkstation IFA: 2025-06-30
• 04049016140368 - Dehydroepiandrosterone Sulfate (DHEA-S) ELISA: 2025-06-30