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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
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination FDA UDI
Device Name
SURE-VUE MONO 50 TESTS FDA UDI
Model / Reference
T3018-1001 FDA UDI
Description
SURE-VUE MONO 50 TESTS FDA UDI

Identifiers

Catalog Number
23038006 FDA UDI
Primary DI / UDI-DI
00006136471301 FDA UDI
510(k) Number
K874678 FDA UDI
FDA Product Code
KTN FDA UDI
GMDN Term
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5640 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: Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination

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 Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination.

Cleared under the same submission

K874678 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 ae027fa3-898e-44c0-bc80-e7c68ff659a6 37 fields · synced May 30, 2026