Biotrace™

FDA UDI

Class II (US FDA UDI)

by Terragene S.a.

Identity

Trade Name: BIOTRACE™ FDA UDI
Generic Name: Biological sterilization indicator FDA UDI
Device Name: BIOTRACE™ Auto Read 20 Steam BI Process Challenge Device FDA UDI
Model / Reference: 73130 FDA UDI
Description: BIOTRACE™ Auto Read 20 Steam BI Process Challenge Device FDA UDI

Identifiers

Primary DI / UDI-DI: 07798375772327 FDA UDI
FDA Product Code: FRC FDA UDI
JOJ FDA UDI
GMDN Term: Biological sterilization indicator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Biological sterilization indicator

Biotrace™ by Terragene S.a. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Terragene S.a.

Sources (1)

FDA UDI 6bb6a88a-91f2-41e0-aa98-af1e85d4b83d 35 fields · synced May 30, 2026