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Bionova®

FDA UDI

Class II (US FDA UDI)

by Terragene S.a.

Identity

Trade Name
Bionova® FDA UDI
Generic Name
Biological sterilization indicator FDA UDI
Device Name
Steam Test Pack PCD Kit (16 test packs and 4 control BIs) FDA UDI
Model / Reference
KPCD220-2 FDA UDI
Description
Steam Test Pack PCD Kit (16 test packs and 4 control BIs) FDA UDI

Identifiers

Primary DI / UDI-DI
07798164678526 FDA UDI
510(k) Number
K163646 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
Not 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

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Cleared under the same submission

K163646 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Terragene S.a.

Sources (1)

  • FDA UDI 7b47dd76-8def-4fe3-8dcb-d839a5bf61c3 37 fields · synced Jun 1, 2026