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InTray® COLOREX Screen

FDA UDI

Class I (US FDA UDI)

by Biomed Diagnostics, Inc.

Identity

Trade Name
InTray® COLOREX Screen FDA UDI
Generic Name
Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid FDA UDI
Device Name
For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens. FDA UDI
Model / Reference
1103 FDA UDI
Description
For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens. FDA UDI

Identifiers

Catalog Number
21-103-001 FDA UDI
Primary DI / UDI-DI
B08811030 FDA UDI
FDA Product Code
JSI FDA UDI
GMDN Term
Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid 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 urinary tract pathogen culture isolate identification IVD, kit, rapid

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

Similar devices

Also classified as Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid.

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 26a11ca3-db34-4564-8a57-a5058f8a7ee6 35 fields · synced May 30, 2026