NovaLisa Mycoplasma pneumoniae IgG MYCG0350

GUDID ENTIMYCG03500

The Mycoplasma pneumoniae IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mycoplasma pneumoniae in human serum or plasma (citrate, heparin).

Gold Standard Diagnostics Frankfurt GmbH

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: ENTIMYCG03500
• NIH Device Record Key: 121424cc-7340-459c-9657-b5a7e1b6a12e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaLisa Mycoplasma pneumoniae IgG
• Version Model Number: MYCG0350
• Catalog Number: MYCG0350
• Company DUNS: 330328514
• Company Name: Gold Standard Diagnostics Frankfurt GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ENTIMYCG03500 [Primary]

FDA Product Code

• LJZ: Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-03
• Device Publish Date: 2024-08-26

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