Identity
- Trade Name
- SeroELISA Chlamydia IgA FDA UDI
- Generic Name
- Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- A113-01 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290001913161 FDA UDI
- 510(k) Number
- K914327 FDA UDI
- FDA Product Code
- LJC FDA UDI
- GMDN Term
- Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
SeroELISA Chlamydia IgA by Savyon Diagnostics Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Savyon Diagnostics Ltd
Sources (1)
- FDA UDI 8f3826aa-4e41-455e-86df-bb6d054a8602 35 fields · synced May 30, 2026