Bionova®
Self-contained Biological Indicator for monitoring ethylene oxide sterilization processes with a minimum viable population of 10^7 spores.
1manufacturer
47catalogue 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 | 2022-02-01 |
| Record revised | 2025-09-02 (version 5) |
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 |
| Distribution end date | 2024-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| (K)PCD224-C | In distribution | ||
| KPCD222-2 | In distribution | ||
| (K)PCD222-C | In distribution | ||
| PCD222-C | In distribution | ||
| BT20 | 10 | In distribution | |
| MINIBIO | In distribution | ||
| BT223 | 50 | In distribution | |
| PCD225-C | In distribution | ||
| BT96 | 50 | In distribution | |
| IC10/20FRLCD | In distribution | ||
| KPCD225-2 | In distribution | ||
| PCD224-2 | In distribution | ||
| PCD225-2 | In distribution | ||
| BT220 | 25 | In distribution | |
| BT224 | 25 | In distribution | |
| KPCD220-2 | In distribution | ||
| BT222 | 25 | In distribution | |
| PCD220-C | In distribution | ||
| Hyper Auto-reader incubator (BHY) | In distribution | ||
| IC10/20FR | In distribution | ||
| KPCD225-C | In distribution | ||
| PCD220-2 | In distribution | ||
| BT20 | 30 | In distribution | |
| BT220 | 50 | In distribution | |
| BT110 | 50 | In distribution | |
| PCD222-2 | In distribution | ||
| BT222 | 50 | In distribution | |
| KPCD224-2 | In distribution | ||
| BT224 | 50 | In distribution | |
| BT95 | 50 | In distribution | |
| BT20 | 100 | In distribution | |
| BT221 | 50 | In distribution | |
| BT110 | 50 | In distribution | |
| KPCD220-C | In distribution | ||
| PCD224-C | In distribution | ||
| KPCD222-2 | Withdrawn | ||
| KPCD222-2 | Withdrawn | ||
| KPCD220-2 | Withdrawn | ||
| KPCD220-C | Withdrawn | ||
| (K)PCD222-C | Withdrawn | ||
| (K)PCD224-C | Withdrawn | ||
| (K)PCD224-C | Withdrawn | ||
| KPCD220-C | Withdrawn | ||
| (K)PCD222-C | Withdrawn | ||
| KPCD224-2 | Withdrawn | ||
| KPCD224-2 | Withdrawn | ||
| KPCD220-2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.