GTZ · Class I · 21 CFR 866.3740

FDA Product Code GTZ: Antisera, All Groups, Streptococcus Spp.

Leading manufacturers include Abbott Laboratories, Quidel Corp. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

105

Total

105

Cleared

106d

Avg days

1976

Since

FDA 510(k) Cleared Antisera, All Groups, Streptococcus Spp. Devices (Product Code GTZ)

105 devices

1–24 of 105

Cleared Nov 30, 2001

BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST

MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST

BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)

DIRECTIGEN 1-2-3 GROUP A STREP TEST

K951542

Bd Becton Dickinson Vacutainer Systems Preanalytic

Microbiology · 200d

Cleared Oct 20, 1995

QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)

MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)

ABBOTT TEST PACK STREP A TEST

REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST

K942093

Medical Diagnostic Technologies, Inc.

Microbiology · 210d

Cleared Jul 18, 1994

MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010

QUICKVUE IN-LINE ONE-STEP STREP A TEST

TESTPACK PLUS STREP A

BBL STREP GROUPING KIT

K920565

Bd Becton Dickinson Vacutainer Systems Preanalytic

Biosearch Medical Products, Inc.

Biosearch Medical Products, Inc.

Microbiology · 122d

Cleared Aug 07, 1991

GROUP A STREP POSITIVE AND NEGATIVE CONTROLS

ICON STREP B IMMUNOENZYMETRIC ASSAY

REDITEST STREP A TEST KIT

K903194

Boehringer Mannheim Corp.

Diagnostic Products Corp.

Immunology · 17d

Cleared May 11, 1990

TESTPACK PLUS STREP A

K901274

Abbott Laboratories

Microbiology · 53d

FDA Product Code GTZ: Antisera, All Groups, Streptococcus Spp.

FDA 510(k) Cleared Antisera, All Groups, Streptococcus Spp. Devices (Product Code GTZ)

About Product Code GTZ - Regulatory Context

Related FDA 510(k) Regulatory Insights