Product code GTZ— Microbiology
TESTPACK PLUS STREP A
- Classification name
- Antisera, All Groups, Streptococcus Spp.
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Total cleared
- 105
- First cleared
- Most recent
Market context for product code GTZ
FDA has cleared devices under product code GTZ between 1976 and 2001, filed by 52 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2001
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
Top applicants under product code GTZ
Recent clearances under product code GTZ
1–100 of 105- K012521 — BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
- K011709 — UNI-GOLD STREP A TEST KIT
- K010523 — MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
- K991726 — BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
- K971522 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
- K962060 — STREP A OIA MAX
- K962296 — STREPTOLEX-STAT
- K961423 — OSOM STREP A TEST
- K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
- K955108 — CARDS Q.S. STREP A
- K960712 — BINAX STREP A TEST
- K952819 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
- K951542 — DIRECTIGEN 1-2-3 GROUP A STREP TEST
- K954257 — QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
- K952873 — MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
- K935475 — QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
- K935554 — QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
- K945571 — ABBOTT TEST PACK STREP A TEST
- K934383 — PROLEX (STREPTOCCAL GROUPING LATEX KIT)
- K942093 — REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
- K932482 — MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
- K934484 — QUICKVUE IN-LINE ONE-STEP STREP A TEST
- K924461 — STREP A NEGATIVE CONTROL
- K924007 — QUIKPAC STREP A TEST
- K923673 — PRECISE STREP A
- K922345 — TESTPACK PLUS STREP A
- K920565 — BBL STREP GROUPING KIT
- K915758 — STREP A OIA
- K912889 — OIA STREP A
- K912868 — GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
- K911417 — ICON STREP B IMMUNOENZYMETRIC ASSAY
- K910797 — STREPTEX ACID EXTRACTION KIT
- K903194 — REDITEST STREP A TEST KIT
- K902038 — PATHO DX STREP D
- K901274 — TESTPACK PLUS STREP A
- K896265 — QUIDEL GROUP B STREP TEST
- K897083 — VENTRESIGN STREP A TEST
- K896221 — CARDS O.S.(TM) STREP A
- K895103 — ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
- K896109 — IMMUNOCARD STREP A TEST
- K894711 — ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
- K894122 — LEECO VIS-DISK STREP-A (EIA)
- K893422 — CLEARVIEW STREP A
- K890840 — VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
- K885003 — BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
- K884750 — GROUP A STREP, BETA-STREP
- K883999 — QUIDEL GROUP A STREP TEST
- K881457 — KODAK SURECELL STREP A TEST KIT
- K880483 — V-TREND STREP A TEST
- K880460 — TARGET STREP A
- K880665 — MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
- K874761 — RAPID COLORIMETRIC DIRECT STREP A TEST
- K872904 — BINAX EQUATE STREP B
- K873784 — NOVA STREP A
- K872346 — SURE-STREP A TEST KIT CATALOG NO. MB-1083
- K872961 — QTEST STREP
- K872114 — BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
- K872493 — DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST
- K871620 — ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT
- K871831 — PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
- K870854 — BACTO(R) STREP GROUP KIT
- K870155 — DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
- K864170 — LEECO VIS-CUBE STREP A (EIA)
- K864206 — REVEAL COLOUR STREP A ZL16
- K863908 — BINAX STREP A
- K863647 — CARDS(TM) STREP A CATALOG NO. CR-7545
- K861098 — SEROIDEN STREPTO KIT 'EIKEN'
- K860923 — EZ DETECT, 5 MINUTE STREP-A COLOR TEST
- K860768 — DIRECTIGEN COMBO MENINGITIS TEST
- K860947 — LEECO-SCREEN, STREP A (EIA)
- K860576 — MUREX SUDS GROUP A STREP
- K860778 — TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
- K854978 — DIFCO STREP A LATEX TEST
- K854929 — OXOID STREPTOCOCAL GROUPING KIT
- K860247 — INSTA KIT FOR GROUP A STREP ID
- K854447 — IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
- K852266 — ABBOTT STREP A P.S.D.
- K854150 — PHADIRECT STREP A TEST
- K853073 — CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
- K852806 — QUIDEL QUEST STREP GROUP A TEST
- K852841 — RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
- K851132 — LATEX AGGLUTINATION TEST
- K850772 — BACTIGEN GROUP B STREPTOCOCCUS TEST
- K845022 — PATHO DX LATEX AGGLUTINATION STREP B KIT
- K850256 — CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES
- K850831 — STREP A QUICK
- K844855 — VENTRESCREEN STREP A TEST
- K844399 — RESPIRALEX LATEX AGGLUTINATION TEST
- K843713 — DIRECTIGEN GROUP A STREP TEST KIT
- K844107 — PHARMACIA STREP A DIRECT SWAB TEST
- K843590 — DETECT-A-STREP
- K842827 — STREPTEX DIRECT A ZL14
- K842383 — PATHO DX LATEX AGGLUTINATION STREP A
- K834582 — DETECT GROUP A STREP TEST
- K831991 — DIRECTIGEN GROUP B STREP TEST KIT-SERUM
- K830445 — PHADEBACT STREP F TEST
- K823569 — ABBOTT LABORATORIES STREP A EIA
- K821100 — MERITECASTREP (TM)
- K820069 — WELLCOGEN GROUP B
- K801775 — SERO STREP KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.