ZDMC

Primary DI
06976045540242
Brand
ZDMC
Company
Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.
Model
1 test/kit
Device description
This kit is intended for qualitative detection of the matrix metalloproteinase-9 (MMP-9) in human ocular surface rinsing fluid for the auxiliary diagnosis of dry eye disease.
Published
2023-03-17
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
PFQMmp-9 Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFQMmp-9 Test SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976045540242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976045540242069760455402426976045540242

GMDN Terms#

Term, Definition table
TermDefinition
Matrix metalloproteinase-9 (MMP-9) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of matrix metalloproteinase-9 (MMP-9) in a clinical specimen, using a enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
601499444
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30014613336747InflammaDryQUIDEL CORPORATIONPFQ2019-08-02