small dense LDL Control Set 08834105190

GUDID 04987503563088

DENKA COMPANY LIMITED

Low density lipoprotein (LDL) cholesterol IVD, control Low density lipoprotein (LDL) cholesterol IVD, control Low density lipoprotein (LDL) cholesterol IVD, control Low density lipoprotein (LDL) cholesterol IVD, control Low density lipoprotein (LDL) cholesterol IVD, control Low density lipoprotein (LDL) cholesterol IVD, control Low density lipoprotein (LDL) cholesterol IVD, control Low density lipoprotein (LDL) cholesterol IVD, control

• Primary Device ID: 04987503563088
• NIH Device Record Key: eeadd4f8-45cc-40dc-bf2a-b0cd48ccc00c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: small dense LDL Control Set
• Version Model Number: 08834105190
• Catalog Number: 08834105190
• Company DUNS: 694830238
• Company Name: DENKA COMPANY LIMITED
• 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: 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
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987503563088 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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

Devices Manufactured by DENKA COMPANY LIMITED

• 04987503562883 - small dense LDL Seiken: 2020-10-21
• 04987503562890 - small dense LDL Seiken: 2020-10-21
• 04987503563071 - small dense LDL Calibrator: 2020-10-21
• 04987503563088 - small dense LDL Control Set: 2020-10-21
• 04987503563088 - small dense LDL Control Set: 2020-10-21