Diamedix

GUDID 00817273020327

"720-610 EBV-VCA IgM Test Kit"

DIAMEDIX CORPORATION

Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00817273020327
• NIH Device Record Key: 5e4d99ea-013f-493e-94a6-266ac2addd99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diamedix
• Version Model Number: 720-610
• Company DUNS: 151765328
• Company Name: DIAMEDIX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817273020327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982352

FDA Product Code

• LSE: Epstein-Barr Virus, Other

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Diamedix]

• 00817273020471: Mago 4S Anayzer
• 00817273020464: MAGO 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"
• 00817273020099: 720-260 anti-SSB Test Kit
• 00817273020082: 720-250 anti-SSA Test Kit
• 00817273020075: 720-240 anti-SM Test Kit
• 00817273020068: 720-230 ENA-6 Screen Test Kit
• 00817273020051: 720-130 H.pylori IgG Test Kit
• 00817273020044: "300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit"
• 00817273020037: 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit
• 00817273020020: "300-312A Toxoplasma IgM Capture Lyoph. Ag. Accessory Kit"
• 00817273020013: 251-035 ProbeClean Concentration Kit"
• 00817273020006: Calibration Test Kit