Verify Assert
The VERIFY Assert STEAM Process Challenge Device for Dynamic Air Removal Cycles, contains 25 challenge packs and 5 controls.
1manufacturer
4catalogue numbers in this listing
35510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K200126 |
| Record published | 2017-07-27 |
| Record revised | 2023-11-14 (version 7) |
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 humidity 30 to 60 % RH; Storage environment temperature 60 to 75 °F |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| LCB032 | 25 | In distribution | |
| LCB031 | 25 | In distribution | |
| LCB033 | 25 | In distribution | |
| LCB043 | 25 | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K260766 | 2026-04-08 |
| K252680 | 2025-09-24 |
| K251452 | 2025-06-06 |
| K250061 | 2025-02-06 |
| K250044 | 2025-02-06 |
| K233681 | 2023-12-15 |
| K231490 | 2023-08-07 |
| K223715 | 2023-06-15 |
| K223717 | 2023-06-15 |
| K213881 | 2022-07-21 |
| K220473 | 2022-03-18 |
| K202721 | 2021-01-08 |
| K200126 | 2020-05-22 |
| K190297 | 2019-05-14 |
| K183294 | 2019-01-03 |
| K181686 | 2018-07-24 |
| K181429 | 2018-06-13 |
| K173488 | 2018-03-01 |
| K173633 | 2018-02-28 |
| K173629 | 2018-02-21 |
| K173626 | 2018-02-21 |
| K173670 | 2018-02-12 |
| K173634 | 2018-02-12 |
| K172752 | 2018-02-09 |
| K172474 | 2017-12-29 |
| K171587 | 2017-08-22 |
| K171504 | 2017-08-22 |
| K170070 | 2017-04-28 |
| K140499 | 2014-07-17 |
| K140708 | 2014-06-16 |
| K092906 | 2009-12-30 |
| K083665 | 2009-09-01 |
| K090514 | 2009-03-16 |
| K073618 | 2009-01-07 |
| K073244 | 2008-05-28 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-12-12 | Class II | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to mo | 105 boxes | |
| 2022-12-12 | Class II | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to mo | 857 boxes | |
| 2022-12-12 | Class II | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to mo | 60 boxes | |
| 2022-12-12 | Class II | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to mo | 338 boxes | |
| 2013-09-10 | Class II | Use error | STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a resul | 1,238 boxes | 2014-02-14 |
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.