ID CORE XT

Basic Information

• Brand Name: ID CORE XT
• Primary DI: 08437013457019
• Version / Model: v3
• Catalog Number: 1021720000
• Company Name: PROGENIKA BIOPHARMA, SA
• Labeler DUNS: 464176127
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-02
• Public Version: 2
• Public Version Date: 2025-05-09
• Public Version Status: Update
• Public Device Record Key: cf083aa6-c6cd-43e8-8b7c-dd42b83a16ac

Device Description

ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEP	Molecular Erythrocyte Typing Test	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437013457019	GS1

Premarket Submissions

Submission Number	Supplement Number
BP170154	0

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius