Who else makes this device?

Name: Spore Strip
Brand: Spore Strip

General Hospital › MonitoringIndicator, Biological Sterilization Process

Spore Strip

Mesa Labs atrophaeus spore strips for Ethylene oxide/Dry Heat, 10e4 population. 100 count package.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

3510(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 Spore Strip
Listed by	Mesa Laboratories, Inc., United States
FDA product code	FRC
Device type	Indicator, Biological Sterilization Process
Device class	Class 2
Regulation	21 CFR 880.2800
Establishment	Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2025-01-15

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Spore Strip
Catalogue number	Size	Per pack	Status
10e4		100	In distribution
10e4		100	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
K140589	2014-12-03
K122362	2013-03-26
K112018	2012-01-30

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.