Diamedix

GUDID 00817273020273

"720-460 anti-TG IgG Test Kit"

DIAMEDIX CORPORATION

Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00817273020273
• NIH Device Record Key: a8f7bbe8-6acd-4b9c-969b-59525ee6a695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diamedix
• Version Model Number: 720-460
• 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

Customer Support Contacts

• Phone: 305-324-2300
• Email: customerservice@erbadiagnostics.com
• Phone: 305-324-2300
• Email: customerservice@erbadiagnostics.com
• Phone: 305-324-2300
• Email: customerservice@erbadiagnostics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817273020273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984228

FDA Product Code

• JZO: System, Test, Thyroid Autoantibody

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

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• 00817273020273: "720-460 anti-TG IgG Test Kit"
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• 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"
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• 00817273020204: "720-370 Rubella IgM Test Kit"
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• 00817273020181: "720-350 HSV 1&2 IgM Test Kit"
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• 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"
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• 00817273020105: "720-270 anti-SM/RNP Test Kit"
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• 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"
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