Identity
- Trade Name
- Chlamydia Trachomatis IgG 120 Test Kit FDA UDI
- Generic Name
- Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- I-CTR01G FDA UDI
Identifiers
- Catalog Number
- I-CTR01G FDA UDI
- Primary DI / UDI-DI
- 00813545025519 FDA UDI
- 510(k) Number
- K914953 FDA UDI
- FDA Product Code
- LKI FDA UDI
- GMDN Term
- Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Chlamydia Trachomatis IgG 120 Test Kit by Scimedx Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.
Cleared under the same submission
K914953 also covers:
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
- Scimedx Corp.
Sources (1)
- FDA UDI f7d05ee5-8b08-4c15-a897-296863fa1466 35 fields · synced May 31, 2026