AccessGUDID - DEVICE: FETALSCREEN™II (10758750006144)

GUDID

Device Identifier (DI) Information

Brand Name: FETALSCREEN™II
Version or Model: Z488
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALBA BIOSCIENCE LIMITED

Primary DI Number: 10758750006144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 516536641 *Terms of Use

Device Description: FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.

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):	Yes
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?
55977	Foeto-maternal haemorrhage/Kleihauer test IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of foetal red blood cells in a maternal clinical specimen, also known as a Kleihauer test, as an indicator of foeto-maternal haemorrhage.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTI	Kit, Cell Screening, Fetal

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: 906f7e41-dc9d-480b-a37f-3a2a8226c3ca
Public Version Date: January 29, 2025
Public Version Number: 7
DI Record Publish Date: March 29, 2017