AccessGUDID - DEVICE: Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides (10888234100065)

GUDID

Device Identifier (DI) Information

Brand Name: Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides
Version or Model: 800-20202-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-20202-08
Company Name: BIOARRAY SOLUTIONS LTD

Primary DI Number: 10888234100065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 949103725 *Terms of Use

Device Description: No description.

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:	Yes
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?
60726	Multiple blood group genotyping IVD, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine the genotype for multiple blood groups using a nucleic acid technique (NAT). The blood group systems to be genotyped may include Rhesus (CcDEe), Kell (K, k, Kp^a, Kp^b), Duffy (Fy^a, Fy^b, Fy^x), Kidd (Jk^a, Jk^b), Lewis (Le^a, Le^b), MNS (M, N, S, s, U), Xg (Xg^a), Dombrock (Do^a, Do^b), Colton (Co^a, Co^b), Cartwright (Yt^a, Yt^b), Lutheran (Lu^a, Lu^b) and/or Diego (Di^a, Di^b). Some types may, in addition determine ABO blood groups.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEP	Molecular Erythrocyte Typing Test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP130026	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
Special Storage Condition, Specify: store reagent box in -80 to -20 degrees Celsius
Special Storage Condition, Specify: store carrier box in 2 to 8 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 167eec6c-fc59-403d-8124-72fd92bd6e58
Public Version Date: May 09, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2014