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Light Diagnostics ™ Enterovirus 71/ Coxsackie A16 Monoclonal Antibody
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Light Diagnostics ™ Enterovirus 71/ Coxsackie A16 Monoclonal Antibody FDA UDI
- Generic Name
- Enterovirus antigen (serotypes 68-71) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Enterovirus 71/ Coxsackie A16 Monoclonal Antibody FDA UDI
- Model / Reference
- 3323 FDA UDI
- Description
- Enterovirus 71/ Coxsackie A16 Monoclonal Antibody FDA UDI
Identifiers
- Catalog Number
- 3323 FDA UDI
- Primary DI / UDI-DI
- 04053252469404 FDA UDI
- 510(k) Number
- K940473 FDA UDI
- FDA Product Code
- GOE FDA UDI
- GMDN Term
- Enterovirus antigen (serotypes 68-71) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3405 FDA UDI
- Commercial Distribution
- Not 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
No
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
Light Diagnostics ™ Enterovirus 71/ Coxsackie A16 Monoclonal Antibody by Emd Millipore Corporation — 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
- Emd Millipore Corporation
Sources (1)
- FDA UDI 9254ef08-02ad-4b82-b664-7588b8ce2f97 38 fields · synced Jun 1, 2026