Who else makes this device?

Name: Sterlink™
Brand: Sterlink™

General Hospital › MonitoringIndicator, Biological Sterilization Process

Sterlink™

Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophilus bacterial spores and is intended for monitoring the…

Registry build 21.09.26

Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydorgen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60 degree celsius.

1manufacturer

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FRC
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15

Record

Regulatory record for Sterlink™
Listed by	Plasmapp Co., Ltd., South Korea
FDA product code	FRC
Device type	Indicator, Biological Sterilization Process
Device class	Class 2
Regulation	21 CFR 880.2800
Establishment	Repacker / relabeller, Manufacturer
510(k)	K212193
Record published	2021-11-26

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 10 to 30 °C; Storage environment humidity 30 to 80 % RH

Catalogue Numbers

Catalogue numbers for Sterlink™
Catalogue number	Size	Status
BT96		In distribution
Mini-bio		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bionova®	Terragene S.A.	47
Attest™	3M Company	36
Verify	Steris Corporation	27
3M™ Attest™	3M Company	16
Celerity	Steris Corporation	15
Biotrace™	Terragene S.A.	11
Single Species BI Strip	Crosstex International	11
Tuttnauer®	Terragene S.A.	10
Sterrad Velocity™	Advanced Sterilization Products Services Inc.	8
GPS	Group Practice Solutions	7
Henry Schein	Henry Schein, Inc.	7
Propper Duo Spore Biological Indicators	Propper Manufacturing Co., Inc.	7

Showing 12 of 173. All products under Indicator, Biological Sterilization Process

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K223023	2023-05-09
K212193	2021-10-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.