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Elecsys Anti-TSHR

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys Anti-TSHR FDA UDI
Generic Name
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
08496609190 FDA UDI

Identifiers

Catalog Number
08496609190 FDA UDI
Primary DI / UDI-DI
07613336160305 FDA UDI
510(k) Number
K193313 FDA UDI
FDA Product Code
JZO FDA UDI
GMDN Term
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5870 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: Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay

Elecsys Anti-TSHR by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K193313 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 b04f7099-a35b-41e4-8e26-81551a5d9ec8 35 fields · synced Jun 8, 2026