OSU · Class II · 21 CFR 866.3945

FDA Product Code OSU: Dengue Serological Reagents

Dengue Virus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Detection Of Anti-dengue Antibodies, Individuals That Have Signs And Symptoms Consistent With Dengue. The Detection Aids In The Clinical Laboratory Diagnosis Of Dengue Fever Or Dengue Hemorrhagic Fever Caused By Dengue Virus. The Device Is Intended For Use In The Presumptive Diagnosis Of Patients In Conjunction With Other Clinical And Laboratory Findings.

1
Total
0
Cleared
170d
Avg days
2011
Since

FDA 510(k) Cleared Dengue Serological Reagents Devices (Product Code OSU)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OSU - Regulatory Context