AccessGUDID - DEVICE: Capture-P Ready-Screen (10888234001287)

GUDID

Device Identifier (DI) Information

Brand Name: Capture-P Ready-Screen
Version or Model: 0066247
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0066247
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234001287
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: Capture-P Ready-Screen solid phase system is used to detect IgG HLA and platelet specific antibodies to platelets. This is a single microplate product.

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):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
56576	Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used in screening and/or identification of one or multiple antibodies to human platelet antigen (HPA) systems, which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15, in a clinical specimen using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSS	Supplies, Blood-Bank

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK880022	0

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: 801ae02b-2697-40e2-85a2-359d02b4671d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 14, 2016