Identity
- Trade Name
- MultiCode® Enterovirus Primers FDA UDI
- Generic Name
- Enterovirus nucleic acid (serotypes 68-71) IVD, reagent FDA UDI
- Device Name
- Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens FDA UDI
- Model / Reference
- 3903 FDA UDI
- Description
- Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens FDA UDI
Identifiers
- Catalog Number
- 3903 FDA UDI
- Primary DI / UDI-DI
- 00840487101254 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Enterovirus nucleic acid (serotypes 68-71) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Enterovirus nucleic acid (serotypes 68-71) IVD, reagent
MultiCode® Enterovirus Primers by Luminex Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Luminex Corporation
Sources (1)
- FDA UDI 1cb9aceb-1389-42a1-858d-cd21ea522fc6 36 fields · synced Jun 9, 2026