Identity
- Trade Name
- MHV DNA Amplification Control FDA UDI
- Generic Name
- Endogenous DNA/RNA internal control IVD, reagent FDA UDI
- Device Name
- Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. FDA UDI
- Model / Reference
- 3694 FDA UDI
- Description
- Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. FDA UDI
Identifiers
- Catalog Number
- 3694 FDA UDI
- Primary DI / UDI-DI
- 00840487101100 FDA UDI
- FDA Product Code
- OLD FDA UDI
- GMDN Term
- Endogenous DNA/RNA internal control IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Endogenous DNA/RNA internal control IVD, reagent
MHV DNA Amplification Control by Luminex Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endogenous DNA/RNA internal control IVD, reagent.
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- MHV DNA Sample Processing Control — Luminex Corporation · Class I
- MHV DNA Sample Processing Control — Luminex Corporation · Class I
- MHV DNA Sample Processing Control — Luminex Corporation · Class I
- MHV DNA Sample Processing Control — Luminex Corporation · 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 |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA UDI 0559a26b-5dee-4bda-ae88-3a52ce507651 36 fields · synced Jun 9, 2026