small dense LDL Seiken 08834059190

GUDID 04987503562883

DENKA COMPANY LIMITED

Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

• Primary Device ID: 04987503562883
• NIH Device Record Key: b5f389ce-d1cf-4329-9746-143c175416ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: small dense LDL Seiken
• Version Model Number: 08834059190
• Catalog Number: 08834059190
• Company DUNS: 694830238
• Company Name: DENKA COMPANY LIMITED
• 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: 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: 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
• 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	04987503562883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161679

FDA Product Code

• PYP: Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

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: 2020-10-21
• Device Publish Date: 2020-10-13

On-Brand Devices [small dense LDL Seiken]

• 04987503562890: 08834075190
• 04987503562883: 08834059190