Who is the manufacturer of SAS SALMONELLA H FACTOR 5 ANTISERUM?

Sa Scientific, Inc. submitted the Traditional clearance for SAS SALMONELLA H FACTOR 5 ANTISERUM (K955212).

What is the FDA product code for SAS SALMONELLA H FACTOR 5 ANTISERUM?

GNC. It is classified under 21 CFR 866.3550 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for SAS SALMONELLA H FACTOR 5 ANTISERUM?

510(k) clearance (submission type: Traditional).

SAS SALMONELLA H FACTOR 5 ANTISERUM

K955212 · Sa Scientific, Inc. · GNC · Feb 7, 1996 · Microbiology

Device Facts

Record ID	K955212
Device Name	SAS SALMONELLA H FACTOR 5 ANTISERUM
Applicant	Sa Scientific, Inc.
Product Code	GNC · Microbiology
Decision Date	Feb 7, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3550
Device Class	Class 2

Regulatory Classification

Identification

Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Salmonella spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Salmonella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genus Salmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever (“enteric fever”), severe diarrhea, and cramps.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.