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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Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived)
JANT PHARMACAL CORPORATION
PF851
In Commercial Distribution

  • 10763924851109 ()
  • 00763924851102 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
VITROS Chemistry Products AMPH Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801991
In Commercial Distribution

  • 10758750001774 ()
  • 20758750001771 ()
6801991

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
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
48 Tests
In Commercial Distribution

  • 08437013457101 ()
1292320000

  • Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)
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)
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 EDTA. 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
48 tests
In Commercial Distribution

  • 08437013457033 ()
1291720000

  • Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)
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 EDTA. 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
v1
In Commercial Distribution

  • 08437013457026 ()
1291780000

  • Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)
Pressure Monitoring Line with Nafion Dryer (BioMed Private Label) - SINGLE, EACHES LEVEL
MAXTEC, LLC
R229P18-001
In Commercial Distribution

  • 00817770026068 ()


  • Gas-sampling/monitoring respiratory tubing, single-use
cryoICE cryoFORM Corrugated 10cm Cryoablation Probe
ATRICURE, INC.
CRYOF
In Commercial Distribution

  • 00818354017908 ()

  • Length: 10 Centimeter
A000957-6

  • General cryosurgical system, cryogen gas, mechanical
cryoICE 10cm Cryoablation Probe
ATRICURE, INC.
CRYO3
In Commercial Distribution

  • 00818354017892 ()

  • Length: 10 Centimeter
A000925-6

  • General cryosurgical system, cryogen gas, mechanical
cryoICE 10cm Cryoablation Probe
ATRICURE, INC.
CRYO2
In Commercial Distribution

  • 00818354017885 ()

  • Length: 10 Centimeter
A000683-6

  • General cryosurgical system, cryogen gas, mechanical
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