SteriTec Smart-Read Biological Test Pack with Instant Readout Integrator

FDA UDI

Class II (US FDA UDI)

by Steritec Product Mfg. Co., Inc.

Identity

Trade Name: SteriTec Smart-Read Biological Test Pack with Instant Readout Integrator FDA UDI
Generic Name: Biological sterilization indicator FDA UDI
Device Name: BI 108 = 30 tests + 5 controls BI 108/30 = 30 tests + 30 controls FDA UDI
Model / Reference: BI 108 FDA UDI
Description: BI 108 = 30 tests + 5 controls BI 108/30 = 30 tests + 30 controls FDA UDI

Identifiers

Catalog Number: BI 108, BI 108/30 FDA UDI
Primary DI / UDI-DI: 00814434020059 FDA UDI
FDA Product Code: FRC 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

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

FDA UDI

Category: Biological sterilization indicator

The SteriTec Smart-Read Biological Test Pack with Instant Readout Integrator is a precise sterilization indicator designed for biological testing applications. This single-use device ensures accurate and reliable results in various laboratory settings. By displaying a change in color when exposed to effective sterilization parameters, it provides instant feedback on the success of sterilization processes. The SteriTec Smart-Read Biological Test Pack with Instant Readout Integrator is ideal for implantable products and medical devices requiring precise sterilization monitoring.

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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: Steritec Product Mfg. Co., Inc.

Sources (1)

FDA UDI a4d6ee9c-c5bf-407b-b570-1fc40d796f80 35 fields · synced Jun 20, 2026