FDA.reportPublic FDA data

MeMed Key®

Primary DI
17290018739003
Brand
MeMed Key®
Company
MEMED DIAGNOSTICS LTD
Model
FG130001
Published
2021-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QPSImmunoassay For Host Biomarkers Of Infection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPSImmunoassay For Host Biomarkers Of InfectionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210254000MeMed BVMeMed Diagnostics, Ltd.2021-09-01QPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290018739003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001873900317290018739003

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533243445
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290018739089MeMed BV® CalibratorFG310012023-07-17
17290018739072Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP FG000042022-09-22
17290018739010MeMed BV®FG100012021-12-06
17290018739027MeMed BV® CalibratorFG110012021-10-26
17290018739034MeMed BV® External ControlFG120012021-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17290018739089MeMed BV® CalibratorMEMED DIAGNOSTICS LTDQPS2023-07-17
08056771602969LIAISON MeMed BVDiasorin Inc.QPS2022-08-10
17290018739010MeMed BV®MEMED DIAGNOSTICS LTDQPS2021-12-06
17290018739027MeMed BV® CalibratorMEMED DIAGNOSTICS LTDQPS2021-10-26
17290018739034MeMed BV® External ControlMEMED DIAGNOSTICS LTDQPS2021-10-26