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Chemdye®

FDA UDI

Class II (US FDA UDI)

by Terragene S.a.

Identity

Trade Name
Chemdye® FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Bowie-Dick Test Card FDA UDI
Model / Reference
BD8948X/1 FDA UDI
Description
Bowie-Dick Test Card FDA UDI

Identifiers

Primary DI / UDI-DI
07798164677864 FDA UDI
510(k) Number
K200272 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Chemical/physical sterilization process 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

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

Category: Chemical/physical sterilization process indicator

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

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Cleared under the same submission

K200272 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 8832e860-f207-4638-9742-6dca0dc2686e 36 fields · synced Jun 6, 2026