AccessGUDID - DEVICE: Lumipulse G HE4 Calibrators (04987270234181)

GUDID

Device Identifier (DI) Information

Brand Name: Lumipulse G HE4 Calibrators
Version or Model: 234181
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIREBIO INC.

Primary DI Number: 04987270234181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 710873907 *Terms of Use

Device Description: No description.

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Human epididymis protein 4 (HE4) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of human epididymis protein 4 (HE4) ovarian cancer marker, in a clinical specimen.

FDA Product Code

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Product Code	Product Code Name
JIT	Calibrator, Secondary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151378	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: right side up with care; No vibration
Storage Environment Temperature: between 2 and 10 Degrees Celsius
Handling Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size Type = Units Per Kit; Units = 2; Unit of Measure = 3.0mLs

Device Record Status

Public Device Record Key: 01fe4b9c-5328-4d90-954c-38eeff9493fd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016