FDA.reportPublic FDA data

Diamedix

Primary DI
00817273020440
Brand
Diamedix
Company
DIAMEDIX CORPORATION
Model
789-008
Device description
"""789-008 EZ Complement Low Control"""
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DHLProtein, Complement, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHLProtein, Complement, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817273020440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817273020440008172730204408172730204400817273020440

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
305-324-2300customerservice@erbadiagnostics.com

Regulatory Flags#

DUNS number
151765328
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817273020167Diamedix720-3302016-09-20
00817273020181Diamedix720-3502016-09-20
00817273020044Diamedix300-371A2016-09-20
00817273020013Diamedix251-0352016-09-20
00817273020372Diamedix720-7002016-09-20
00817273020006Diamedix250-0302016-09-20
00817273020020Diamedix300-312A2016-09-20
00817273020037Diamedix300-331A2016-09-20
00817273020051Diamedix720-1302016-09-20
00817273020068Diamedix720-2302016-09-20
00817273020075Diamedix720-2402016-09-20
00817273020082Diamedix720-2502016-09-20
00817273020099Diamedix72-2602016-09-20
00817273020105Diamedix720-2702016-09-20
00817273020112Diamedix720-2802016-09-20
00817273020129Diamedix720-2902016-09-20
00817273020136Diamedix720-3002016-09-20
00817273020143Diamedix720-3102016-09-20
00817273020150Diamedix720-3202016-09-20
00817273020174Diamedix720-3402016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049095260049RIDA® CCD-InhibitorR-Biopharm AGDHL2023-07-03
10634853000169Fungal SerologyMICROBIOLOGICS INC.DHL2022-09-26
B1761080Antiserum to Human ProperdinKENT LABORATORIES INCDHL2016-09-24
B1761082Anti Human Properdin FITCKENT LABORATORIES INCDHL2016-09-24
B1761212Anti Human C3b Inactivator FITCKENT LABORATORIES INCDHL2016-09-24
00817273020457DiamedixDIAMEDIX CORPORATIONDHL2016-09-21
00817273020426DiamedixDIAMEDIX CORPORATIONDHL2016-09-20
00817273020433DiamedixDIAMEDIX CORPORATIONDHL2016-09-20