True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 10^5 bacterial…
True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 10^5 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple. One box contains 100 SCBIs. For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for True Indicating | Listed by | True Indicating LLC, United States |
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K200970 |
| Record published | 2024-05-01 |
| Record revised | 2024-11-11 (version 2) |
Specifications
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, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment temperature 20 to 80 % RH |
| Distribution end date | 2027-03-25 |
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.