Lipid Control S-Ⅰ

GUDID 04987503563019

Low density lipoprotein (LDL) cholesterol IVD, control

Primary Device ID	04987503563019
NIH Device Record Key	6868f2fb-f5a9-4019-8def-5794ba81cf0b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Lipid Control S-Ⅰ
Version Model Number	563019
Company DUNS	694830238
Company Name	DENKA SEIKEN CO., LTD.
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	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

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

Device Issuing Agency	Device ID
GS1	04987503563019 [Primary]

JJY	Multi-Analyte Controls, All Kinds (Assayed)

Steralize Prior To Use	false
Device Is Sterile	false