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InTray® DM

FDA UDI

Class I (US FDA UDI)

by Biomed Diagnostics, Inc.

Identity

Trade Name
InTray® DM FDA UDI
Generic Name
Multiple dermatophyte species culture isolate identification IVD, kit FDA UDI
Device Name
An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens. FDA UDI
Model / Reference
2063 FDA UDI
Description
An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens. FDA UDI

Identifiers

Catalog Number
22-063-000 FDA UDI
Primary DI / UDI-DI
B08820630 FDA UDI
FDA Product Code
JSI FDA UDI
GMDN Term
Multiple dermatophyte species culture isolate identification IVD, kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2360 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple dermatophyte species culture isolate identification IVD, kit

InTray® DM by Biomed Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple dermatophyte species culture isolate identification IVD, kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomed Diagnostics, Inc.

Sources (1)

  • FDA UDI 5fe6a40a-c01e-4abc-bec4-5aa0d95ac6a4 35 fields · synced Jun 8, 2026