Lysozym ELISA

GUDID 04050598169005

Immundiagnostik AG

Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04050598169005
• NIH Device Record Key: cc0fb5eb-0524-40b0-b2d6-aff1a063c8fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lysozym ELISA
• Version Model Number: K 6900
• Company DUNS: 321663841
• Company Name: Immundiagnostik AG
• 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: false
• 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: false
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04050598169005 [Primary]

FDA Product Code

• JMQ: M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)

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: 2023-06-29
• Device Publish Date: 2023-06-21

Devices Manufactured by Immundiagnostik AG

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• 04050598000452 - Lysozyme ELISA: 2023-06-29
• 04050598000469 - Lysozyme ELISA: 2023-06-29
• 04050598000872 - α2-Makroglobulin ELISA: 2023-06-29
• 04050598007673 - IDK® sIgA ELISA: 2023-06-29
• 04050598008540 - IDK® Pancreatic Elastase ELISA: 2023-06-29
• 04050598010406 - Lactoferrin ELISA: 2023-06-29
• 04050598010413 - Lactoferrin ELISA: 2023-06-29