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InTray DM-FungID

FDA UDI

Class I (US FDA UDI)

by Biomed Diagnostics, Inc.

Identity

Trade Name
InTray DM-FungID FDA UDI
Generic Name
Multiple dermatophyte species culture isolate identification IVD, kit FDA UDI
Device Name
InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota. FDA UDI
Model / Reference
1593 FDA UDI
Description
InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota. FDA UDI

Identifiers

Catalog Number
21-593-001 FDA UDI
Primary DI / UDI-DI
B08815930 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-FungID 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 4095c25a-987f-4304-bff3-b0833b2a3606 35 fields · synced Jun 6, 2026