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Sure-Vue

FDA UDI

Class II (US FDA UDI)

by Fisher Scientific Company L.l.c.

Identity

Trade Name
Sure-Vue FDA UDI
Generic Name
Rubella virus total antibody IVD, kit, rapid agglutination, clinical FDA UDI
Device Name
SELECT RUBELLA 500 TST/PK FDA UDI
Model / Reference
T3018-4012 FDA UDI
Description
SELECT RUBELLA 500 TST/PK FDA UDI

Identifiers

Catalog Number
23038062 FDA UDI
Primary DI / UDI-DI
00006136471240 FDA UDI
510(k) Number
K954920 FDA UDI
FDA Product Code
LQN FDA UDI
GMDN Term
Rubella virus total antibody IVD, kit, rapid agglutination, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3510 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: Rubella virus total antibody IVD, kit, rapid agglutination, clinical

Sure-Vue by Fisher Scientific Company L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rubella virus total antibody IVD, kit, rapid agglutination, clinical.

Cleared under the same submission

K954920 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fisher Scientific Company L.l.c.

Sources (1)

  • FDA UDI d9ac0f12-7579-4964-9ab6-b4580fd7e15d 37 fields · synced May 30, 2026