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Device Explorer · FDA GUDID · GMDN 13732

Biological sterilization indicator

A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcom

US‑registered devices358in commercial distribution
Companies34labelers on GUDID
Single‑use98%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Mesa Laboratories, Inc.6217%
Terragene S.A.5114%
3M Company4312%
Crosstex International, Inc.308%
Sps Medical Supply Corp.308%
Steris Corporation298%
Propper Manufacturing Company, Inc.195%
Steritec Product Mfg. Co., Inc.175%

Top labelers

CompanyDevicesShare
Mesa Laboratories, Inc.6217%
Terragene S.A.5114%
3M Company4312%
Crosstex International, Inc.308%
Sps Medical Supply Corp.308%
Steris Corporation298%
Propper Manufacturing Company, Inc.195%
Steritec Product Mfg. Co., Inc.175%
Mckesson Medical-Surgical Inc.93%
True Indicating Llc82%
Safco Dental Supply Co.51%
Hu-Friedy Mfg. Co., Llc51%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AN2203.04 - Biological Indicators for EtO (50 UnLarr-Test 24ApprovedExcelsior ScientificTrue IndicatingSPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTSPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTHealth-Tec Biological Monitoring SystemSmartPracticeN' Sure EZTest Bio Stream IndicatorsN'Sure Indicator StripsN'Sure Dry Heat Indicator LabelSafco Tru-Verify™ MonitorSporAmpule®Getinge Assured Self-Contained Biological IndicaGetinge Assured Self-Contained Biological Indica

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FRCIndicator, Biological Sterilization Process222
FRCIndicator, biological sterilization process175
JOJIndicator, Physical/Chemical Sterilization Process36
JOJIndicator, physical/chemical sterilization process12
MRBIndicator, Biological, Liquid Chemical Sterilization Process8
QVBBiological Sterilization Indicator With Indirect Growth Dete2

GMDN & GCC registration

  • GMDN code 13732 · non‑implantable
  • Single‑use 98% · sterile 0% · Rx‑only 1% · OTC 43%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Area/Surface Area (Square inch) · 1

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many biological sterilization indicator products are registered in the US?

358 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Biological sterilization indicator", from 34 companies. The largest labeler is Mesa Laboratories, Inc. with 17% of records.

Which FDA product codes apply?

FRC (Indicator, Biological Sterilization Process), FRC (Indicator, biological sterilization process), JOJ (Indicator, Physical/Chemical Sterilization Process), JOJ (Indicator, physical/chemical sterilization process)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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