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ONLINE TDM Procainamide

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
ONLINE TDM Procainamide FDA UDI
Generic Name
Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
08252661190 FDA UDI

Identifiers

Catalog Number
08252661190 FDA UDI
Primary DI / UDI-DI
07613336147900 FDA UDI
510(k) Number
K060773 FDA UDI
FDA Product Code
LAR FDA UDI
GMDN Term
Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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: Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ONLINE TDM Procainamide by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K060773 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI 6e14f9b1-4cf0-481b-874f-c0250b6e6b28 35 fields · synced May 30, 2026