SeroELISA Chlamydia IgA

GUDID 07290001913161

The SeroELISAChlamydia IgA kit is intended for the determination of specific IgA antibodies to Chlamydia in a single human serum sample by an Enzyme-Linked Immunosorbent Assay (ELISA). For In Vitro Diagnostic Use.

SAVYON DIAGNOSTICS LTD

Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07290001913161
• NIH Device Record Key: 8f3826aa-4e41-455e-86df-bb6d054a8602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeroELISA Chlamydia IgA
• Version Model Number: A113-01
• Company DUNS: 533708202
• Company Name: SAVYON DIAGNOSTICS LTD
• 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: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290001913161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914327

FDA Product Code

• LJC: Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

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: 2025-06-06
• Device Publish Date: 2025-05-29

Devices Manufactured by SAVYON DIAGNOSTICS LTD

• 07290001913147 - SeroELISA Chlamydia IgG: 2025-06-06 The SeroELISA Chlamydia IgG kit is intended for the determination of specific IgG antibody to Chlamydia in a single human serum
• 07290001913161 - SeroELISA Chlamydia IgA: 2025-06-06The SeroELISAChlamydia IgA kit is intended for the determination of specific IgA antibodies to Chlamydia in a single human serum sample by an Enzyme-Linked Immunosorbent Assay (ELISA). For In Vitro Diagnostic Use.
• 07290001913161 - SeroELISA Chlamydia IgA: 2025-06-06 The SeroELISAChlamydia IgA kit is intended for the determination of specific IgA antibodies to Chlamydia in a single human serum
• 07290013348302 - Conjugate IgA: 2023-07-07 Conjugate IgA
• 07290013348470 - Conjugate IgM: 2023-07-07 Conjugate IgM
• 07290013348487 - Bordetella immunology reagents IgA: 2023-07-07 Bordetella immunology reagents IgA- IgA Sera pack
• 07290013348494 - Bordetella immunology reagents IgM: 2023-07-07 Bordetella immunology reagents IgM- IgM sera pack
• 07290016332193 - Serum Diluent IgM: 2023-07-07 Serum Diluent IgM
• 07290016332636 - Bordetella Pertussis IgG: 2023-06-26 Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antib