Synovasure® 00-8888-125-05

GUDID 00887868358821

CD DIAGNOSTICS, INC.

Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00887868358821
NIH Device Record Key1b44c9a6-5b0c-4f0e-93ea-3b8d3256d006
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynovasure®
Version Model Number00-8888-125-05
Catalog Number00-8888-125-05
Company DUNS027871090
Company NameCD DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)348-2759
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868358821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QGNLateral Flow Immunochromatography Assay For Host Infection Biomarkers

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-17
Device Publish Date2019-07-09

On-Brand Devices [Synovasure®]

0088786835885200-8888-125-02
0088786835884500-8888-125-30
0088786835883800-8888-125-10
0088786835882100-8888-125-05
0088786835881400-8888-125-01

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.