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 |
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 |