| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10888234102670 | 800-20301 | 800-20301 | NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | Carrier Box, ETC, Slide, IVD | |
| 2 | 10888234102212 | 790-20006-RF | 790-20006-RF | NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | BioArray Assay Imaging System TM (AIS) 400C | |
| 3 | 10888234100928 | 800-10242 | 800-10242 | PEP | Molecular Erythrocyte Typing Test | 3 | Filled Vial,HotStarTaq DNA Polymerase | |
| 4 | 10888234100683 | 800-00195 | 800-00195 | PEP | Molecular Erythrocyte Typing Test | 3 | Filled Vial, Lambda Exonuclease | |
| 5 | 10888234100645 | 800-00193 | 800-00193 | PEP | Molecular Erythrocyte Typing Test | 3 | Filled Vial, eMAPTM Elongation Mix | |
| 6 | 10888234102618 | 800-20202-96 | 800-20202-96 | PEP | Molecular Erythrocyte Typing Test | 3 | Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate | |
| 7 | 10888234102205 | 790-20006 | 790-20006 | NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | BioArray Assay Imaging SystemTM (AIS) 400C | |
| 8 | 10888234100669 | 800-00194 | 800-00194 | PEP | Molecular Erythrocyte Typing Test | 3 | Filled Vial, HEA 1.2 PCR Mix | |
| 9 | 10888234100065 | 800-20202-08 | 800-20202-08 | PEP | Molecular Erythrocyte Typing Test | 3 | Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides | |
| 10 | 10888234100836 | 800-00287 | 800-00287 | PEP | Molecular Erythrocyte Typing Test | 3 | Filled Vial,Negative Control 1mL | |
| 11 | 10888234102229 | 790-20016 | 790-20016 | NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | BioArray Assay Imaging System TM (AIS) 400D | |
| 12 | 10888234102236 | 790-20016-RF | 790-20016-RF | NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | BioArray Assay Imaging System TM (AIS) 400D | |
| 13 | 10888234102632 | 800-20236 | 800-20236 | PFK | Quality Control For Molecular Immunohematology Tests | 2 | Precise TypeTM HEA BeadCheck Kit | |
| 14 | 10888234102328 | 800-00229 | 800-00229 | PFK | Quality Control For Molecular Immunohematology Tests | 2 | BeadCheck HEA Ref-pB, Bulk and Fill | |
| 15 | 10888234100621 | 800-00191 | 800-00191 | PEP | Molecular Erythrocyte Typing Test | 3 | Filled Vial, Clean-up, 330uL |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10888234102632 | 800-20236 | 800-20236 | Precise TypeTM HEA BeadCheck Kit | BIOARRAY SOLUTIONS LTD | |
| 2 | 10888234102328 | 800-00229 | 800-00229 | BeadCheck HEA Ref-pB, Bulk and Fill | BIOARRAY SOLUTIONS LTD | |
| 3 | 10888234102298 | 800-00228 | 800-00228 | BeadCheck HEA Ref-pA, Bulk and Fill | BIOARRAY SOLUTIONS LTD | |
| 4 | 10195594046347 | SMA29DDFG1 | SMA29DDFG1 | D AND C PACK | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 5 | 08437013457040 | v1 | 1301790000 | The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple allelesencoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology. | ID CORE CONTROL | PROGENIKA BIOPHARMA, SA |