Lactate Dehydrogenase Assay SK327-20

GUDID 00628063401109

SEKISUI DIAGNOSTICS, LLC

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

• Primary Device ID: 00628063401109
• NIH Device Record Key: 000339ed-8060-461e-93d1-c0f83bbf7120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lactate Dehydrogenase Assay
• Version Model Number: SK327-20
• Catalog Number: SK327-20
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• 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: 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	00628063401109 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-25
• Device Publish Date: 2018-09-24

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