MeMed BV® Calibrator

Primary DI
17290018739089
Brand
MeMed BV® Calibrator
Company
MEMED DIAGNOSTICS LTD
Model
FG31001
Published
2023-07-17
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
K230944000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230944000MeMed BVMeMed Diagnostics, Ltd.2023-06-30QPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290018739089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001873908917290018739089

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cell-mediated host immune response marker IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or (semi-)quantitative detection of multiple cell-mediated (i.e., non-immunoglobulin) host immune response markers of bacterial and/or viral infection in a clinical specimen. It is typically used to aid in the differentiation of bacterial and viral infection, and/or to predict patient outcomes by grading disease severity.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533243445
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290018739072Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP FG000042022-09-22
17290018739010MeMed BV®FG100012021-12-06
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
08056771602969LIAISON MeMed BVDiasorin Inc.QPS2022-08-10
17290018739010MeMed BV®MEMED DIAGNOSTICS LTDQPS2021-12-06
17290018739003MeMed Key®MEMED DIAGNOSTICS LTDQPS2021-10-26
17290018739027MeMed BV® CalibratorMEMED DIAGNOSTICS LTDQPS2021-10-26
17290018739034MeMed BV® External ControlMEMED DIAGNOSTICS LTDQPS2021-10-26