Synovasure® Alpha Defensin

Primary DI
70887868540669
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

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

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 1-3 IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative detection of alpha defensin 1-3 in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses to detect indirect markers of infection and/or inflammation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
027871090
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868540660Synovasure® Alpha Defensin00-8888-125-0500-8888-125-052022-04-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868540660Synovasure® 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