Microalbuminuria Kit (Immunoturbidimetric Method)

GUDID 06970291985222

Medicalsystem Biotechnology Co., Ltd.

Albumin IVD, kit, nephelometry/turbidimetry Albumin IVD, kit, nephelometry/turbidimetry Albumin IVD, kit, nephelometry/turbidimetry Albumin IVD, kit, nephelometry/turbidimetry Albumin IVD, kit, nephelometry/turbidimetry Albumin IVD, kit, nephelometry/turbidimetry Albumin IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 06970291985222
• NIH Device Record Key: a793dfc9-7a4d-4ca4-8491-8a59875dbc57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microalbuminuria Kit (Immunoturbidimetric Method)
• Version Model Number: None
• Company DUNS: 545261989
• Company Name: Medicalsystem Biotechnology Co., Ltd.
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970291985222 [Primary]

FDA Product Code

• DCF: Albumin, Antigen, Antiserum, Control

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: 2019-03-15
• Device Publish Date: 2019-03-07

Devices Manufactured by Medicalsystem Biotechnology Co., Ltd.

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• 06970291985161 - Haptoglobin Kit (Immunoturbidimetric Method): 2019-03-15
• 06970291985178 - Lactate Dehydrogenase Kit (Kinetic Method): 2019-03-15
• 06970291985185 - Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Metho: 2019-03-15
• 06970291985192 - Total Protein Kit (Biuret Method): 2019-03-15
• 06970291985208 - Total Protein Kit (Biuret Method) (2-Part Reagents: 2019-03-15
• 06970291985215 - β2-Microglobin Kit (Latex-Enhanced Immunoturbidim: 2019-03-15
• 06970291985222 - Microalbuminuria Kit (Immunoturbidimetric Method): 2019-03-15
• 06970291985222 - Microalbuminuria Kit (Immunoturbidimetric Method): 2019-03-15