GQS · Class I · 21 CFR 866.3400

FDA Product Code GQS: Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4

Leading manufacturers include Baxter Diagnostics, Inc., Diagnostic Hybrids, Inc. and Orion Diagnostica, Inc..

11
Total
11
Cleared
135d
Avg days
1980
Since

FDA 510(k) Cleared Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 Devices (Product Code GQS)

11 devices
1–11 of 11
Cleared Dec 23, 2009
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
K093415
Diagnostic Hybrids, Inc.
Microbiology · 51d
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
K884193
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
K884194
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Dec 31, 1980
PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR
K802935
Orion Diagnostica, Inc.
Microbiology · 42d

About Product Code GQS - Regulatory Context