| Primary Device ID | 07290001913147 |
| NIH Device Record Key | 00dd6e47-8247-4160-89fb-a6abb5f5fe6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SeroELISA Chlamydia IgG |
| Version Model Number | A111-01 |
| Catalog Number | A111-01 |
| 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 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07290001913147 [Primary] |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-06 |
| Device Publish Date | 2025-05-29 |
| 07290001913147 - SeroELISA Chlamydia IgG | 2025-06-06The SeroELISA Chlamydia IgG kit is intended for the determination of specific IgG antibody to Chlamydia in a single human serum sample or to evaluate paired sera, by an Enzyme-Linked Immunosorbent Assay (ELISA). |
| 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 | 2025-06-06 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 |