s LDL-EX "SEIKEN"

GUDID 04987503562791

DENKA SEIKEN CO., LTD.

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