amdilabs.comFast PCR Base Station - Fast PCR Base Station is part of the Fast PCR Instrument. The Fast PCR Instrument is an automated in vitro diagnostic (IVD) device intended for use with compatible Fast PCR Test Discs.
2026-08-26
AUTONOMOUS MEDICAL DEVICES INCORPORATED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3023999024 | 3023999024 | AUTONOMOUS MEDICAL DEVICES INCORPORATED | 1 | N | 2026-01-01 | 3511 W Sunflower Ave Santa Ana CA US 92704 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850025770002 | Fast PCR Base Station - Fast PCR Base Station is part of the Fast PCR Instrument. The Fast PCR Instrument is an automated in vitro diagnostic (IVD) device intended for use with compatible Fast PCR Test Discs. | (657) 660-6800 | customerservice@amdilabs.com |
| 00850025770019 | Fast PCR Mini Respiratory Panel Test Disc - The Fast PCR Mini Respiratory Panel Test Disc is one of the components of the Fast PCR Mini Respiratory Panel Kit. The Fast PCR Mini Respiratory Panel is an automated, multiplexed real time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B and respiratory syncytial virus (RSV) nucleic acids in anterior nasal swab specimens obtained from individuals with signs and symptoms of respiratory tract infections. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B and RSV infections in humans and is not intended to detect influenza C virus infection. | (657) 660-6800 | customerservice@amdilabs.com |
| 00850025770026 | Fast PCR Operating Module - The Fast PCR Operating Module is part of the Fast PCR Instrument. The Fast PCR Instrument is an automated in vitro diagnostic (IVD) device intended for use with compatible Fast PCR Test Discs. | (657) 660-6800 | customerservice@amdilabs.com |
| 00850025770033 | Fast PCR Mini Respiratory Panel Positive External Control - The Fast PCR Mini Respiratory Panel Positive External Control is a component of the Fast PCR Mini Respiratory Panel External Control Kit. The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only. | (657) 660-6800 | customerservice@amdilabs.com |
| 00850025770040 | Fast PCR Mini Respiratory Panel Negative External Control - The Fast PCR Mini Respiratory Panel Negative External Control is a component of the Fast PCR Mini Respiratory Panel External Control Kit. The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only. | (657) 660-6800 | customerservice@amdilabs.com |
| 00850025770057 | Fast PCR Mini Respiratory Panel External Control Kits (10 Pos + 10 Neg) - The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only. | (657) 660-6800 | customerservice@amdilabs.com |
| 00850025770088 | Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 20) - The Fast PCR Mini Respiratory Panel is an automated, multiplexed real time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B and respiratory syncytial virus (RSV) nucleic acids in anterior nasal swab specimens obtained from individuals with signs and symptoms of respiratory tract infections. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B and RSV infections in humans and is not intended to detect influenza C virus infection. | (657) 660-6800 | customerservice@amdilabs.com |
| 00850025770118 | Fast PCR Mini Respiratory Panel Positive External Control Kits (5 Pos) - The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only. | (657) 660-6800 | customerservice@amdilabs.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 351637 | 1936982318 | K252932 | Fast PCR Mini Respiratory Panel | QOF | 2026-06-12 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QOF | 1 | 2026-06-12 |
GUDID#
Fast PCR Mini Respiratory Panel Test Disc - The Fast PCR Mini Respiratory Panel Test Disc is one of the components of the Fast PCR Mini Respiratory Panel Kit. The Fast PCR Mini Respiratory Panel is an automated, multiplexed real time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B and respiratory syncytial virus (RSV) nucleic acids in anterior nasal swab specimens obtained from individuals with signs and symptoms of respiratory tract infections. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B and RSV infections in humans and is not intended to detect influenza C virus infection.
2026-08-26
Fast PCR Operating Module - The Fast PCR Operating Module is part of the Fast PCR Instrument. The Fast PCR Instrument is an automated in vitro diagnostic (IVD) device intended for use with compatible Fast PCR Test Discs.
2026-08-26
Fast PCR Mini Respiratory Panel Positive External Control - The Fast PCR Mini Respiratory Panel Positive External Control is a component of the Fast PCR Mini Respiratory Panel External Control Kit. The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only.
2026-08-26
Fast PCR Mini Respiratory Panel Negative External Control - The Fast PCR Mini Respiratory Panel Negative External Control is a component of the Fast PCR Mini Respiratory Panel External Control Kit. The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only.
2026-08-26
Fast PCR Mini Respiratory Panel External Control Kits (10 Pos + 10 Neg) - The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only.
2026-08-26
Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 20) - The Fast PCR Mini Respiratory Panel is an automated, multiplexed real time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B and respiratory syncytial virus (RSV) nucleic acids in anterior nasal swab specimens obtained from individuals with signs and symptoms of respiratory tract infections. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B and RSV infections in humans and is not intended to detect influenza C virus infection.
2026-08-26
Fast PCR Mini Respiratory Panel Positive External Control Kits (5 Pos) - The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only.
2026-08-26
Fast PCR Mini Respiratory Panel Negative External Control Kits (5 Neg) - The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only.
2026-08-26
Fast PCR Mini Respiratory Panel External Control Kits, Small Format (5Pos+5Neg) - The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only.
2026-08-26
Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 10) - The Fast PCR Mini Respiratory Panel is an automated, multiplexed real time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B and respiratory syncytial virus (RSV) nucleic acids in anterior nasal swab specimens obtained from individuals with signs and symptoms of respiratory tract infections. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B and RSV infections in humans and is not intended to detect influenza C virus infection.
2026-08-26