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Cytomegalovirus IgG 120 Tests

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
Cytomegalovirus IgG 120 Tests FDA UDI
Generic Name
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
I-CMV01G FDA UDI

Identifiers

Catalog Number
I-CMV01G FDA UDI
Primary DI / UDI-DI
00813545025489 FDA UDI
510(k) Number
K882835 FDA UDI
FDA Product Code
GQH FDA UDI
GMDN Term
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3175 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

Yes

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: Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Cytomegalovirus IgG 120 Tests by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K882835 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 34161dca-892f-4fca-b73d-6638672f264f 35 fields · synced May 31, 2026