AccessGUDID - DEVICE: L-Type LDL-C Reagent 2 (14987481164540)

GUDID

Device Identifier (DI) Information

Brand Name: L-Type LDL-C Reagent 2
Version or Model: 999-00504
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 999-00504
Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION

Primary DI Number: 14987481164540
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 690598875 *Terms of Use

Device Description: In-Vitro Diagnostic Use

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53398	Low density lipoprotein (LDL) cholesterol IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBR	Ldl & Vldl Precipitation, Hdl

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982271	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef24b186-5326-42e3-9c9e-318f4637d6a4
Public Version Date: June 09, 2021
Public Version Number: 1
DI Record Publish Date: June 01, 2021