LanaGram™, rapid color test for bacterial gram reaction, 15 tests per package For organisms that are difficult to gram stain. Uses the aminopeptidase reaction. LanaGram™ confirms the gram…
LanaGram™, rapid color test for bacterial gram reaction, 15 tests per package For organisms that are difficult to gram stain. Uses the aminopeptidase reaction. LanaGram™ confirms the gram stain reaction of gram-negative and gram-positive aerobic or facultatively anaerobic rods or coccobacilli. This test is not recommended for use with gram-positive cocci, microaerophilic or obligate anaerobic organisms.
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1).
Record
Regulatory record for LanaGram™ | Listed by | Hardy Diagnostics, United States |
| FDA product code | JSF |
| Device type | Culture Media, Single Biochemical Test |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2320 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-16 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | 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.