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Brand Name: cCeLL
Device Name: cCeLL - Ex vivo
Model Name:CX100-2W2C488775
VPIX Medical, Inc.
CX100-2W2C488775
In Commercial Distribution
- 08800112400192 ()
- Scanning laser optical microscope
No Description
Carl Zeiss Meditec AG
6918
In Commercial Distribution
- 04049539069184 ()
- Scanning laser optical microscope
Sterilization Wrap,Double Layer Two Color,Purple & Blue,V300,54 X 90
Vivit Supply LLC
590DL
In Commercial Distribution
- 20810141933198 ()
- 10810141933191 ()
- 00810141933194 ()
- Sterilization packaging, single-use
Sterilization Wrap,Double Layer Two Color,Purple & Blue,V500,36 X 36
Vivit Supply LLC
536DL
In Commercial Distribution
- 20810141933181 ()
- 10810141933184 ()
- 00810141933187 ()
- Sterilization packaging, single-use
Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
HEMO BIOSCIENCE INC
H9200
In Commercial Distribution
- 00858352006009 ()
H9200
- Multiple blood group genotyping IVD, control
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 alleles
encoding 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.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution
- 08437013457040 ()
1301790000
- Multiple blood group genotyping IVD, control
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.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution
- 08437013457019 ()
1021720000
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution
- 10888234102632 ()
800-20236
- Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution
- 10888234102618 ()
800-20202-96
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution
- 10888234102328 ()
800-00229
- Multiple blood group genotyping IVD, control