AccessGUDID - DEVICE: Panoscreen I, II, and III (10888234000303)

GUDID

Device Identifier (DI) Information

Brand Name: Panoscreen I, II, and III
Version or Model: 0002381
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0002381
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234000303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: Panoscreen I, II, and III is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuration of this product is a 3-cell screen.

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:	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
Storage Environment Temperature: between 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9784b8e1-a18b-45a6-b033-8002479699eb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2014