AccessGUDID - DEVICE: CH50 Calibrator (00856626006151)

GUDID

Device Identifier (DI) Information

Brand Name: CH50 Calibrator
Version or Model: 997-43801
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 997-43801
Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION

Primary DI Number: 00856626006151
Issuing Agency: GS1
Commercial Distribution End Date: October 23, 2020
Device Count: 1
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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
53662	Total complement activity (CH50) 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 total complement activity (CH50 ) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DAE	Complement C9, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954145	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 -10 Degrees Celsius or lower

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54c80851-f3d0-412e-abde-e0acfc7f7fa1
Public Version Date: October 26, 2020
Public Version Number: 5
DI Record Publish Date: December 07, 2016