AccessGUDID - DEVICE: L-Type HDL-C (Reagent 1) (10856626006042)

GUDID

Device Identifier (DI) Information

Brand Name: L-Type HDL-C (Reagent 1)
Version or Model: 991-00101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 991-00101
Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION

Primary DI Number: 10856626006042
Issuing Agency: GS1
Commercial Distribution End Date: October 23, 2020
Device Count: 4
Labeler D-U-N-S® Number*: 690598875 *Terms of Use

Device Description: The L-Type HDL-C is an in vitro assay for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in serum. (4 each 600 mL)

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. Do not freeze.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9867f573-577a-4d61-ae74-cd3169932e15
Public Version Date: March 08, 2022
Public Version Number: 6
DI Record Publish Date: November 11, 2016