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ID indole TDA

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
ID indole TDA FDA UDI
Generic Name
Tryptophan utilization/spot indole microbial reagent IVD FDA UDI
Device Name
Detection in enterobacteria of indole production and the presence of a tryptophan deaminase (TDA). It allows presumptive differentiation of bacteria possessing these characteristics FDA UDI
Model / Reference
ID indole TDA FDA UDI
Description
Detection in enterobacteria of indole production and the presence of a tryptophan deaminase (TDA). It allows presumptive differentiation of bacteria possessing these characteristics FDA UDI

Identifiers

Primary DI / UDI-DI
03573026092443 FDA UDI
FDA Product Code
JSS FDA UDI
GMDN Term
Tryptophan utilization/spot indole microbial reagent IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

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: Tryptophan utilization/spot indole microbial reagent IVD

ID indole TDA by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tryptophan utilization/spot indole microbial reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI e2d7e7bf-4aa0-4fce-bdb2-6f2a9a68bc00 34 fields · synced May 30, 2026