MeMed Key®

GUDID 17290018739003

MEMED DIAGNOSTICS LTD

Chemiluminescent immunoassay analyser IVD, automated
Primary Device ID17290018739003
NIH Device Record Key88cf4e11-830c-4176-a5f6-3a0caeff1f41
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeMed Key®
Version Model NumberFG130001
Company DUNS533243445
Company NameMEMED DIAGNOSTICS LTD
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290018739003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QPSImmunoassay For Host Biomarkers Of Infection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-03
Device Publish Date2021-10-26

Devices Manufactured by MEMED DIAGNOSTICS LTD

17290018739089 - MeMed BV® Calibrator2023-07-25
17290018739072 - Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP 2022-09-30 The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare profes
17290018739010 - MeMed BV®2021-12-14
17290018739003 - MeMed Key®2021-11-03
17290018739003 - MeMed Key®2021-11-03
17290018739027 - MeMed BV® Calibrator2021-11-03
17290018739034 - MeMed BV® External Control2021-11-03

Trademark Results [MeMed Key]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEMED KEY
MEMED KEY
79260427 not registered Live/Pending
MeMed Diagnostics Ltd.
2019-02-24

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