LACTATE DEHRYDROGENASE-SL Assay 327-30

GUDID 00628063400652

SEKISUI DIAGNOSTICS, LLC

Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00628063400652
• NIH Device Record Key: 57f1c47b-6b4d-4f6b-859e-42eb9c1a3e47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LACTATE DEHRYDROGENASE-SL Assay
• Version Model Number: 327-30
• Catalog Number: 327-30
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628063400652 [Primary]

FDA Product Code

• CFJ: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

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