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Cytomegalovirus 10wl/10 pk

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
Cytomegalovirus 10wl/10 pk FDA UDI
Generic Name
Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
I-CMV01X FDA UDI

Identifiers

Catalog Number
I-CMV01X FDA UDI
Primary DI / UDI-DI
00813545025502 FDA UDI
510(k) Number
K882835 FDA UDI
FDA Product Code
GQH FDA UDI
GMDN Term
Cytomegalovirus (CMV) antigen 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

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: Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay

Cytomegalovirus 10wl/10 pk by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytomegalovirus (CMV) antigen 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 7e77626f-ddeb-4b25-a05a-346b32c23309 35 fields · synced May 31, 2026