Dna-Reagents, Mycoplasma Spp.
FDA product code LQG · Class I (low risk) · 21 CFR 866.3375 · Microbiology
1510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860574 | Gen-Probe Mycoplasma Pneumonia Rapid Detect SystemLQG · Traditional | Gen-Probe, Inc. | 07/03/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0746-2026 Class II | Mycoplasma test, IgG and IgMDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |