Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
antigens, all groups, streptococcus spp.
Product Code
GTY
Regulation Number
866.3740
Device Class
1
Premarket Reviews
Manufacturer
Decision
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
1
BINAX, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K091489
CLEARVIEW ADVANCED STREP A , MODEL 737-430
GUANGZHOU WONDFO BIOTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HEALGEN SCIENTIFIC, LLC
SUBSTANTIALLY EQUIVALENT
1
QUIDEL CORPORATION
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2017
2
2
2018
12
12
2019
6
6
2020
1
1
2021
37
37
2022
32
32
2023
44
44
2024
16
16
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
59
59
False Negative Result
43
43
Incorrect, Inadequate or Imprecise Result or Readings
33
33
Break
3
3
Fire
2
2
Defective Component
2
2
Component Missing
1
1
Defective Device
1
1
Chemical Spillage
1
1
Contamination of Device Ingredient or Reagent
1
1
Detachment of Device or Device Component
1
1
Device Markings/Labelling Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Inaccurate Information
1
1
Missing Information
1
1
Leak/Splash
1
1
Material Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
123
123
No Consequences Or Impact To Patient
21
21
No Code Available
3
3
Choking
2
2
Bacterial Infection
2
2
No Information
2
2
Abdominal Pain
1
1
Unspecified Infection
1
1
Red Eye(s)
1
1
Chemical Exposure
1
1
No Known Impact Or Consequence To Patient
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alere San Diego
II
Feb-22-2012
2
Biosite Inc Dba Innovacon Inc.
II
Feb-22-2011
3
Jay Bird Investments Inc
II
Aug-23-2011
4
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
5
Remel Inc
II
Aug-07-2015
-
-