The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in…
The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Alethia Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Alethia™ Mycoplasma Direct External Control Kit | Listed by | Meridian Bioscience, Inc., United States |
| FDA product code | OZX |
| Device type | Mycoplasma Pneumoniae Dna Assay System |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3980 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K160829 |
| Record published | 2019-01-08 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
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.