s LDL-EX "SEIKEN"

GUDID 04987503562791

DENKA SEIKEN CO., LTD.

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: 04987503562791
• NIH Device Record Key: 660b1609-0325-4980-aa42-38635bf95e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s LDL-EX "SEIKEN"
• Version Model Number: 562791
• Company DUNS: 694830238
• Company Name: DENKA SEIKEN CO., LTD.
• 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: true
• 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

Customer Support Contacts

• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx
• Phone: +1 408-371-8819
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *shading
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *shading

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987503562791 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-21
• Device Publish Date: 2018-06-29

On-Brand Devices [s LDL-EX "SEIKEN"]

• 04987503562807: 562807
• 04987503562791: 562791
• 04987503562760: 562760