FDA UDI
In Commercial Distribution
🇺🇸 United States
SeroELISA Chlamydia IgA
DI: 07290001913161
·
Model: A113-01
·
SAVYON DIAGNOSTICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SeroELISA Chlamydia IgA
- Primary DI
- 07290001913161
- Version / Model
- A113-01
- Company Name
- SAVYON DIAGNOSTICS LTD
- Labeler DUNS
- 533708202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-29
- Public Version
- 1
- Public Version Date
- 2025-06-06
- Public Version Status
- New
- Public Device Record Key
- 8f3826aa-4e41-455e-86df-bb6d054a8602
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | Microbiology | 866.3120 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50741 | Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to Chlamydia pneumoniae bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290001913161 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K914327 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius