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Elecsys PreciControl Tumor Marker

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys PreciControl Tumor Marker FDA UDI
Generic Name
Multiple tissue-associated protein/tumour marker IVD, control FDA UDI
Model / Reference
11776452160 FDA UDI

Identifiers

Catalog Number
11776452160 FDA UDI
Primary DI / UDI-DI
04015630938780 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple tissue-associated protein/tumour marker 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

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: Multiple tissue-associated protein/tumour marker IVD, control

Elecsys PreciControl Tumor Marker by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple tissue-associated protein/tumour marker IVD, control.

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 e218fb8a-c7ea-463e-ae5b-85e7f2529ef6 34 fields · synced May 31, 2026