AccessGUDID - DEVICE: AIA-PACK FSH Calibration Verification Test Set (04560189212268)

GUDID

Device Identifier (DI) Information

Brand Name: AIA-PACK FSH Calibration Verification Test Set
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOSOH CORPORATION

Primary DI Number: 04560189212268
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690571724 *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:	Yes
Prescription Use (Rx):	No
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?
38254	Follicle stimulating hormone (FSH) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7646eec3-0c02-4d05-bdb2-09d15de52dd0
Public Version Date: April 01, 2024
Public Version Number: 3
DI Record Publish Date: July 25, 2019