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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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A1AT Genotyping Test - 08437013457095

The A1AT Genotyping Test uses Polymerase Chain Reaction (PCR) amplification to obtain large amounts of the target sequences in the serpin peptidase inhibitor class A member 1 (SERPINA1) gene. The A1AT Genotyping 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. A1AT Genotyping Test generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is allelic variant genotypes and associated alleles. A1AT genotyping Test simultaneously detects and identifies 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect Dx OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD).
PROGENIKA BIOPHARMA, SA
192 Tests
In Commercial Distribution

  • 08437013457095 ()
1292380000

  • Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)

Jenx - 05056235201212

Standz Core Package Yellow
JENX LIMITED
STZ01-C1-09
In Commercial Distribution

  • 05056235201212 ()


  • Manual stander

Jenx - 05056235201205

Standz Core Package Red
JENX LIMITED
STZ01-C1-04
In Commercial Distribution

  • 05056235201205 ()


  • Manual stander

Jenx - 05056235201199

Standz Core Package Green
JENX LIMITED
STZ01-C1-03
In Commercial Distribution

  • 05056235201199 ()


  • Manual stander

Jenx - 05056235201182

Standz Core Package Pink
JENX LIMITED
STZ01-C1-02
In Commercial Distribution

  • 05056235201182 ()


  • Manual stander

Jenx - 05056235201175

Standz Core Package Blue
JENX LIMITED
STZ01-C1-01
In Commercial Distribution

  • 05056235201175 ()


  • Manual stander

Jenx - 05056235200888

Prone Stander Size 2
JENX LIMITED
PS04
In Commercial Distribution

  • 05056235200888 ()


  • Manual stander

Jenx - 05056235200864

Kangaroo Standing Frame
JENX LIMITED
NR70
In Commercial Distribution

  • 05056235200864 ()


  • Manual stander

Jenx - 05056235200802

Penguin Standing Frame
JENX LIMITED
NR55
In Commercial Distribution

  • 05056235200802 ()


  • Manual stander

Jenx - 05056235200444

Multistander Size 2 Frame Manual Actuator
JENX LIMITED
MUS02-FM-08
In Commercial Distribution

  • 05056235200444 ()


  • Manual stander
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