Biotrace™
BIOTRACE™ Auto Read 20 Steam BI Process Challenge Device
1manufacturer
11catalogue numbers in this listing
5510(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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | Terragene S.A., Argentina |
|---|---|
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| 510(k) | K163646 |
| Record published | 2023-11-13 |
| Record revised | 2025-06-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C; Storage environment humidity 30 to 80 % RH |
| Packaging | Case of 2, case, box of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 73130 | 25 | In distribution | |
| 73135 | 25 | In distribution | |
| 73105 | 50 | In distribution | |
| 73420 | In distribution | ||
| 73410 | In distribution | ||
| 73400 | In distribution | ||
| 73100 | 50 | In distribution | |
| 73430 | In distribution | ||
| 73300 | 50 | In distribution | |
| 73110 | 50 | In distribution | |
| 73120 | 100 | 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 |
| 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 |
| Spore Strip Steam & Chemiclave | Mesa Laboratories, Inc. | 6 |
Showing 12 of 173. All products under Indicator, Biological Sterilization Process
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242453 | 2024-12-12 |
| K231383 | 2024-09-18 |
| K221641 | 2023-02-28 |
| K191021 | 2019-09-13 |
| K163646 | 2017-11-02 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Terragene SA | 510(k) number | 2025-01-15 | Class II | Labeling False and Misleading | Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes. | 914 devices in the U.S. |
| Terragene SA | 510(k) number | 2023-12-07 | Class II | Labeling False and Misleading | Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. | 80 stripes |
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.