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EBV VCA IgG 10 wl +1 more model

FDA UDI

Class I (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
EBV VCA IgG 10 wl; 10 pk FDA UDI
Generic Name
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
I-EBV01X FDA UDI

Identifiers

Catalog Number
I-EBV01X FDA UDI
Primary DI / UDI-DI
00813545025564 FDA UDI
510(k) Number
K900974 FDA UDI
FDA Product Code
JRY FDA UDI
GMDN Term
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Models / Variants
EBV VCA IgG 10 wl FDA UDI
10 pk FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3235 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

No

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) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

EBV VCA IgG 10 wl +1 more model by Scimedx Corp. — Class I — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

Similar devices

Also classified as Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K900974 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI 83f8c3c0-6508-4a7f-b40a-1c0b7de08567 35 fields · synced May 30, 2026