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Id Core Xt

FDA UDI

Class III (US FDA UDI)

by Progenika Biopharma, Sa

Identity

Trade Name
ID CORE XT FDA UDI
Generic Name
Multiple blood group genotyping IVD, nucleic acid technique (NAT) FDA UDI
Device Name
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. FDA UDI
Model / Reference
v3 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
1021720000 FDA UDI
Primary DI / UDI-DI
08437013457019 FDA UDI
FDA Product Code
PEP FDA UDI
GMDN Term
Multiple blood group genotyping IVD, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple blood group genotyping IVD, nucleic acid technique (NAT)

Id Core Xt by Progenika Biopharma, Sa — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood group genotyping IVD, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Progenika Biopharma, Sa

Sources (1)

  • FDA UDI cf083aa6-c6cd-43e8-8b7c-dd42b83a16ac 36 fields · synced May 30, 2026