AccessGUDID - DEVICE: Capture-R Ready-ID Extend II (10888234000693)

GUDID

Device Identifier (DI) Information

Brand Name: Capture-R Ready-ID Extend II
Version or Model: 0006457
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0006457
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234000693
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: Capture-R Ready-ID Extend II is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration of this product is 2 x 8 strips which contain test wells coated with D-negative red cell membranes of 14 group O single donors. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
58814	Solid-phase red blood cell adherence antibody/antigen IVD	A microplate or test strip of protein-activated wells intended to be used in immunohaematological testing of a clinical specimen for the detection and/or identification of red blood cell antibodies or antigens, using a solid-phase red blood cell adherence 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
Storage Environment Temperature: between 1 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1a2a9984-c56f-4619-94a2-1e437648badc
Public Version Date: July 08, 2021
Public Version Number: 3
DI Record Publish Date: June 04, 2016