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., Dako Diagnostics , Ltd. and Diagnostic Hybrids, 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 Jan 09, 1995
IMAGEN
K943557
Dako Diagnostics , Ltd.
Microbiology · 171d
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