A1AT Genotyping Test 1292380000

GUDID 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

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

• Primary Device ID: 08437013457095
• NIH Device Record Key: b40be881-5771-4b9d-b022-69e6eef1c71a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A1AT Genotyping Test
• Version Model Number: 192 Tests
• Catalog Number: 1292380000
• Company DUNS: 464176127
• Company Name: PROGENIKA BIOPHARMA, SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437013457095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211115

FDA Product Code

• PZH: Serpina1 Variant Detection System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [A1AT Genotyping Test]

• 08437013457101: The A1AT Genotyping Test uses Polymerase Chain Reaction (PCR) amplification to obtain large amou
• 08437013457095: The A1AT Genotyping Test uses Polymerase Chain Reaction (PCR) amplification to obtain large amou