AccessGUDID - DEVICE: L-Type HDL-C Reagent 2 (14987481164571)

GUDID

Device Identifier (DI) Information

Brand Name: L-Type HDL-C Reagent 2
Version or Model: 997-00201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 997-00201
Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION

Primary DI Number: 14987481164571
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 690598875 *Terms of Use
Previous DI: 10856626006141

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?
44696	High density lipoprotein (HDL) cholesterol IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	Calibrator, Primary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963847	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
Special Storage Condition, Specify: Store at 2-10C.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa8091a1-50df-4ca8-a5fe-8557949d4cfb
Public Version Date: March 08, 2022
Public Version Number: 3
DI Record Publish Date: October 23, 2020