Identity
- Trade Name
- VALIDATE FDA UDI
- Generic Name
- Methotrexate therapeutic drug monitoring IVD, control FDA UDI
- Device Name
- VALIDATE MTX Calibration Verification / Linearity Test Kit FDA UDI
- Model / Reference
- 310ro FDA UDI
- Description
- VALIDATE MTX Calibration Verification / Linearity Test Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011135761 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Methotrexate therapeutic drug monitoring IVD, control 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
Yes
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: Methotrexate therapeutic drug monitoring IVD, control
Validate by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Methotrexate therapeutic drug monitoring IVD, control.
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- METHOTREXATE LEVEL 3 — UTAK LABORATORIES, INC. · Class I
- METHOTREXATE LEVEL 2 — UTAK LABORATORIES, INC. · Class I
- Methotrexate Level 1 — UTAK LABORATORIES, INC. · Class I
- ARK™ Methotrexate Control — ARK DIAGNOSTICS INC · Class I
- Methotrexate Level 4 — UTAK LABORATORIES, 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 |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI f62bb94b-d9db-4935-b5ca-02ddee318b0c 35 fields · synced Jun 9, 2026