AccessGUDID - DEVICE: INSTANT-VIEW FSH Midstream Cassette Test, 2t (10796918002003)

GUDID

Device Identifier (DI) Information

Brand Name: INSTANT-VIEW FSH Midstream Cassette Test, 2t
Version or Model: 02-2560-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALFA SCIENTIFIC DESIGNS, INC.

Primary DI Number: 10796918002003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 176391167 *Terms of Use

Device Description: INSTANT-VIEW FSH Midstream Cassette Test, 2t

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?
30512	Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of follicle stimulating hormone (FSH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses, and is also available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1a09bd5-06dd-41e6-b3f9-6738d6a201ad
Public Version Date: May 02, 2019
Public Version Number: 2
DI Record Publish Date: October 29, 2018