AccessGUDID - DEVICE: Anti-H (Ulex europaeus) (10888234000723)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-H (Ulex europaeus)
Version or Model: 0007151
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0007151
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234000723
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: Anti-H (Ulex europaeus) is used in the detection of H (H1) antigen on red blood cells and in saliva by tube test. This is a lectin product. This product is in a single vial configuration.

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:	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?
52577	Anti-H red blood cell grouping IVD, lectin	Lectin molecules extracted from plants (e.g., Ulex europaeus, Laburnum alpinum) with the capability of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for H [H001] red blood cell antigens or H substance from the ABO system, using an agglutination or solid-phase red blood cell adherence method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSI	Lectins And Protectins

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: 58c1b6dd-a003-4496-9560-981ae43adaa2
Public Version Date: June 08, 2021
Public Version Number: 3
DI Record Publish Date: April 15, 2016