Identity
- Trade Name
- MERIFLUOR Chlamydia FDA UDI
- Generic Name
- Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- MERIFLUOR Chlamydia is an in vitro direct immunofluorescent detection procedure for the detection of Chlamydia trachomatis and Chlamydia psittaci in McCoy cells FDA UDI
- Model / Reference
- 500111 FDA UDI
- Description
- MERIFLUOR Chlamydia is an in vitro direct immunofluorescent detection procedure for the detection of Chlamydia trachomatis and Chlamydia psittaci in McCoy cells FDA UDI
Identifiers
- Catalog Number
- 500111 FDA UDI
- Primary DI / UDI-DI
- 00840733101205 FDA UDI
- 510(k) Number
- K830342 FDA UDI
- FDA Product Code
- LKI FDA UDI
- GMDN Term
- Multiple Chlamydia species antigen 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
Yes
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: Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay
MERIFLUOR Chlamydia by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay.
- D3 — DIAGNOSTIC HYBRIDS, INC. · Class I
- D3 — DIAGNOSTIC HYBRIDS, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 5d2ff9be-a9b3-48f4-bcc6-93a6d26426af 37 fields · synced Jun 8, 2026