Diamedix

GUDID 00817273020440

"789-008 EZ Complement Low Control"

DIAMEDIX CORPORATION

Plasma protein IVD, control
Primary Device ID00817273020440
NIH Device Record Key3851a9f3-6332-48d4-9e8d-e146d6b4cae4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiamedix
Version Model Number789-008
Company DUNS151765328
Company NameDIAMEDIX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone305-324-2300
Emailcustomerservice@erbadiagnostics.com
Phone305-324-2300
Emailcustomerservice@erbadiagnostics.com
Phone305-324-2300
Emailcustomerservice@erbadiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817273020440 [Primary]

FDA Product Code

DHLProtein, Complement, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-20

On-Brand Devices [Diamedix]

00817273020471Mago 4S Anayzer
00817273020464MAGO Plus chemistry analyzer
00817273020457"789-009 EZ Complement High Control"
00817273020440"789-008 EZ Complement Low Control"
00817273020433"789-006 EZ Complement Reference Serum"
00817273020426"789-001 EZ Complement Cells"
00817273020419"720-850 Mycoplasma IgG Test Kit"
00817273020402"720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit"
00817273020396"720-790 ANA ELISA Screen Test Kit"
00817273020389"720-710 Rheumatoid Factor Test Kit"
00817273020372"720-700 anti-dsDNA Test Kit"
00817273020365"720-650 EBV-EA-D IgM Test Kit"
00817273020358"720-640 EBV-EA-D IgG Test Kit"
00817273020341"720-630 EBNA-1 IgM Test Kit"
00817273020334"720-620 EBNA-1 IgG Test Kit"
00817273020327"720-610 EBV-VCA IgM Test Kit"
00817273020310"720-600 EBV-VCA IgG Test Kit"
00817273020303"720-540 Mumps IgG Test Kit"
00817273020297"720-520 Measles IgG Test Kit"
00817273020280"720-480 anti-Cardiolipin Screen"
00817273020273"720-460 anti-TG IgG Test Kit"
00817273020266"720-450 anti-TPO IgG Test Kit"
00817273020259"720-440 anti-PR-3 (C-ANCA) IgG Test Kit"
00817273020242"720-430 anti-MPO (P-ANCA) IgG Test Kit"
00817273020235"720-420 anti-Cardiolipin IgATest Kit"
00817273020228"720-400 anti-Cardiolipin IgG/IgM Test Kit"
00817273020211"720-380 VZV IgG Test Kit"
00817273020204"720-370 Rubella IgM Test Kit"
00817273020198"720-360 Rubella IgG Test Kit"
00817273020181"720-350 HSV 1&2 IgM Test Kit"
00817273020174"720-340 HSV 1&2 IgG Test Kit"
00817273020167"720-330 CMV IgM Test Kit"
00817273020150"720-320 CMV IgG Test Kit"
00817273020143"720-310 Toxoplasma IgM Test Kit"
00817273020136"720-300 Toxoplasma IgG Test Kit"
00817273020129"720-290 anti-Jo-1 Test Kit"
00817273020112"720-280 anti-Scl-70 Test Kit"
00817273020105"720-270 anti-SM/RNP Test Kit"
00817273020099720-260 anti-SSB Test Kit
00817273020082720-250 anti-SSA Test Kit
00817273020075720-240 anti-SM Test Kit
00817273020068720-230 ENA-6 Screen Test Kit
00817273020051720-130 H.pylori IgG Test Kit
00817273020044"300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit"
00817273020037300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit
00817273020020"300-312A Toxoplasma IgM Capture Lyoph. Ag. Accessory Kit"
00817273020013251-035 ProbeClean Concentration Kit"
00817273020006Calibration Test Kit

Trademark Results [Diamedix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIAMEDIX
DIAMEDIX
74415947 1854431 Live/Registered
Diamedix Corporation
1993-07-23
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