AccessGUDID - DEVICE: Search-Cyte TCS 0.8% (07640137340384)

GUDID

Device Identifier (DI) Information

Brand Name: Search-Cyte TCS 0.8%
Version or Model: 3x10 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 213655
Company Name: Medion Grifols Diagnostics AG

Primary DI Number: 07640137340384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483287020 *Terms of Use

Device Description: Reagent Red Blood Cells for use in the detection of unexpected antibodies in gel technique. For 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):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52544	Antibody screening reagent red blood cell IVD, kit, agglutination	A collection of two or three specifically characterized reagent red blood cells that are supplied together as a set and intended to be used when screening a clinical specimen to detect antibodies to red blood cell antigens, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 5b611afd-1790-4dbd-8c97-d0be70b6719f
Public Version Date: May 13, 2025
Public Version Number: 4
DI Record Publish Date: January 27, 2016