FDA.reportPublic FDA data

MeMed BV®

Primary DI
17290018739010
Brand
MeMed BV®
Company
MEMED DIAGNOSTICS LTD
Model
FG10001
Published
2021-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
17290018739010PrimaryGS10
07290018739013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001873901017290018739010
07290018739013072900187390137290018739013

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-marker bacterial/viral infection differentiation IVD, kit, chemiluminescent immunoassay, rapidA cartridge/card or a collection of reagents and other associated materials intended to be used in the laboratory/point-of-care for the qualitative and/or (semi-)quantitative detection of multiple chemical and/or biological markers to help differentiate bacterial from viral infection in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. Analytes assayed may include C-reactive protein (CRP), myxovirus resistance protein 1 (MxA), tumour necrosis factor-related apoptosis-inducing ligand (TRAIL), and interferon-gamma-induced protein-10 (IP-10). This test is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533243445
Device count
12
Lot or batch
true
Serial number
true
Manufacturing 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
17290018739003MeMed Key®FG1300012021-10-26
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
17290018739003MeMed Key®MEMED DIAGNOSTICS LTDQPS2021-10-26
17290018739027MeMed BV® CalibratorMEMED DIAGNOSTICS LTDQPS2021-10-26
17290018739034MeMed BV® External ControlMEMED DIAGNOSTICS LTDQPS2021-10-26