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Mycoplasma pneumoniae Antigen Substrate, 6 wells, For IFA Test System
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Mycoplasma pneumoniae Antigen Substrate, 6 wells, For IFA Test System FDA UDI
- Generic Name
- Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, reagent FDA UDI
- Model / Reference
- MP-1206 FDA UDI
Identifiers
- Catalog Number
- MP-1206 FDA UDI
- Primary DI / UDI-DI
- B110MP12060 FDA UDI
- FDA Product Code
- LQG FDA UDI
- GMDN Term
- Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3375 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mycoplasma pneumoniae Antigen Substrate, 6 wells, For IFA Test System by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID
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
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI 2604c4f0-9809-468c-b099-7e3685d43e65 36 fields · synced May 31, 2026