Identity
- Trade Name
- ONLINE TDM Methotrexate FDA UDI
- Generic Name
- Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 09230815190 FDA UDI
Identifiers
- Catalog Number
- 09230815190 FDA UDI
- Primary DI / UDI-DI
- 07613336224823 FDA UDI
- 510(k) Number
- K233454 FDA UDI
- FDA Product Code
- LAO FDA UDI
- GMDN Term
- Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- U 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
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
No
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, kit, enzyme immunoassay (EIA)
ONLINE TDM Methotrexate by Roche Diagnostics Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).
- ARK™ Methotrexate Assay — ARK DIAGNOSTICS INC · U
- ARK™ Methotrexate II Assay — ARK DIAGNOSTICS INC · U
- ARK™ Methotrexate Assay (c-pack) — ARK DIAGNOSTICS INC · U
- ARK™ Methotrexate Assay — ARK DIAGNOSTICS INC · U
- ARK™ Methotrexate Assay — ARK DIAGNOSTICS INC · U
- Syva® Emit® Methotrexate Assay — Siemens Healthcare Diagnostics · U
- ARK™ Methotrexate II Assay — ARK DIAGNOSTICS INC · U
- ONLINE TDM Methotrexate — Roche Diagnostics Corp. · U
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 U | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI a77a73cf-7181-49a3-8d5b-1f9308a39f9e 34 fields · synced May 29, 2026