Identity
- Trade Name
- SeroELISA Chlamydia IgG FDA UDI
- Generic Name
- Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The 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). FDA UDI
- Model / Reference
- A111-01 FDA UDI
- Description
- The 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). FDA UDI
Identifiers
- Catalog Number
- A111-01 FDA UDI
- Primary DI / UDI-DI
- 07290001913147 FDA UDI
- 510(k) Number
- K915281 FDA UDI
- FDA Product Code
- LJC FDA UDI
- GMDN Term
- Chlamydia pneumoniae immunoglobulin G (IgG) 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 G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
SeroELISA Chlamydia IgG 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 00dd6e47-8247-4160-89fb-a6abb5f5fe6f 36 fields · synced Jun 8, 2026