Who else makes this device?

Name: Dual Species BI Strip
Brand: Dual Species BI Strip

General Hospital › MonitoringIndicator, Biological Sterilization Process

Dual Species BI Strip

Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical Vapor sterilization processes

Registry build 21.09.26

1manufacturer

6catalogue numbers in this listing

1510(k) clearance

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 Dual Species BI Strip
Listed by	Crosstex International, United States
FDA product code	FRC
Device type	Indicator, Biological Sterilization Process
Device class	Class 2
Regulation	21 CFR 880.2800
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K905425
Record published	2024-03-27
Record revised	2024-03-26 (version 3)

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
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Dual Species BI Strip
Catalogue number	Per pack	Status
DS-100-RED	100	In distribution
DS-100,500,1000	1,000	In distribution
DS-500-RED	500	In distribution
DS-1000-RED	1,000	In distribution
DS-500	500	In distribution
DS-1000	1,000	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
K140620	2014-08-07

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Dual Species BI Strip
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
HF Acquisition Co. LLC	510(k) number	2024-12-11	Class II	Error in labeling	Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer’s account.	4,021
Mckesson Medical-Surgical Inc. Corporate Office	510(k) number	2022-05-25	Class III	Environmental control	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.	a. 60 b. 1 box

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.