FDA.reportPublic FDA data

Synovasure® Alpha Defensin

Primary DI
00887868540660
Brand
Synovasure® Alpha Defensin
Company
CD DIAGNOSTICS, INC.
Model
00-8888-125-05
Catalog number
00-8888-125-05
Published
2022-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QGNLateral flow immunochromatography assay for host infection biomarkers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGNLateral Flow Immunochromatography Assay For Host Infection BiomarkersMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN180032000
K212204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180032000Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control KitCd Diagnostics, Inc.2019-05-23QGN
K212204000Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control KitCd Diagnostics, Inc.2021-08-11QGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868540660PrimaryGS10
70887868540669Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868540660008878685406608878685406600887868540660
7088786854066970887868540669

GMDN Terms#

Term, Definition table
TermDefinition
Alpha defensin IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of alpha defensin in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect indirect markers of infection and/or inflammation. It is not intended to be used for self-testing.

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
027871090
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868540653Synovasure® Alpha Defensin00-8888-125-0100-8888-125-012022-02-04
00887868540677Synovasure® Alpha Defensin00-8888-125-1000-8888-125-102022-02-04
00887868540684Synovasure® Alpha Defensin00-8888-125-3000-8888-125-302022-02-04
00887868540691Synovasure® Alpha Defensin00-8888-125-0200-8888-125-022021-11-21
00887868358814Synovasure® Alpha Defensin00-8888-125-0100-8888-125-012019-07-09
00887868358821Synovasure® Alpha Defensin00-8888-125-0500-8888-125-052019-07-09
00887868358838Synovasure®00-8888-125-1000-8888-125-102019-07-09
00887868358845Synovasure®00-8888-125-3000-8888-125-302019-07-09
00887868358852Synovasure® Alpha Defensin00-8888-125-0200-8888-125-022019-07-09
70887868540669Synovasure® Alpha Defensin00-8888-125-0500-8888-125-052022-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
70887868540669Synovasure® Alpha DefensinCD DIAGNOSTICS, INC.QGN2022-04-07
00887868540653Synovasure® Alpha DefensinCD DIAGNOSTICS, INC.QGN2022-02-04
00887868540677Synovasure® Alpha DefensinCD DIAGNOSTICS, INC.QGN2022-02-04
00887868540684Synovasure® Alpha DefensinCD DIAGNOSTICS, INC.QGN2022-02-04
00887868540691Synovasure® Alpha DefensinCD DIAGNOSTICS, INC.QGN2021-11-21
00887868358814Synovasure® Alpha DefensinCD DIAGNOSTICS, INC.QGN2019-07-09
00887868358821Synovasure® Alpha DefensinCD DIAGNOSTICS, INC.QGN2019-07-09
00887868358838Synovasure®CD DIAGNOSTICS, INC.QGN2019-07-09
00887868358845Synovasure®CD DIAGNOSTICS, INC.QGN2019-07-09
00887868358852Synovasure® Alpha DefensinCD DIAGNOSTICS, INC.QGN2019-07-09