FDA.reportPublic FDA data

Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 10)

Primary DI
00850025770156
Brand
Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 10)
Company
Autonomous Medical Devices Incorporated
Model
AMDI-0066
Device description
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.
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252932000Fast PCR Mini Respiratory PanelAutonomous Medical Devices Incorporated2026-06-12QOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850025770156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025770156008500257701568500257701560850025770156

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
(657) 660-6800customerservice@amdilabs.com

Regulatory Flags#

DUNS number
080095246
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850025770002Fast PCR Base StationFP-BS1AMDI-00172026-08-26
00850025770019Fast PCR Mini Respiratory Panel Test DiscAMDI-00152026-08-26
00850025770026Fast PCR Operating ModuleFP-OM1AMDI-00192026-08-26
00850025770033Fast PCR Mini Respiratory Panel Positive External ControlAMDI-00222026-08-26
00850025770040Fast PCR Mini Respiratory Panel Negative External ControlAMDI-00232026-08-26
00850025770057Fast PCR Mini Respiratory Panel External Control Kits (10 Pos + 10 Neg)AMDI-00452026-08-26
00850025770088Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 20)AMDI-00022026-08-26
00850025770118Fast PCR Mini Respiratory Panel Positive External Control Kits (5 Pos)AMDI-00622026-08-26
00850025770125Fast PCR Mini Respiratory Panel Negative External Control Kits (5 Neg)AMDI-00632026-08-26
00850025770132Fast PCR Mini Respiratory Panel External Control Kits, Small Format (5Pos+5Neg)AMDI-00642026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025770019Fast PCR Mini Respiratory Panel Test DiscAutonomous Medical Devices IncorporatedQOF2026-08-26
00850025770088Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 20)Autonomous Medical Devices IncorporatedQOF2026-08-26
00819704020074FINDER InstrumentBaebies, Inc.QOF2026-05-01
00819704020425FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.QOF2026-05-01
00819704020463FINDER Cleaning AccessoryBaebies, Inc.QOF2026-05-01
00819704020487FINDER RVP BufferBaebies, Inc.QOF2026-05-01
00819704020630FINDER Flu A&B/SARS-CoV-2 Positive Control SwabBaebies, Inc.QOF2026-05-01
00819704020654FINDER Flu A&B/SARS-CoV-2 Negative Control SwabBaebies, Inc.QOF2026-05-01
05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
05061098480032NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007329cobas® Respiratory flex Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007541cobas® Respiratory 4-flexRoche Molecular Systems, Inc.QOF2026-02-24
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCQOF2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCQOF2026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCQOF2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCQOF2026-01-14
04053228039402QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
14053228039409QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
00884999049369Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049376Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049383Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00875197006285cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007299cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007305cobas liat SARS-CoV-2, Influenza A/B & RSV control kitRoche Molecular Systems, Inc.QOF2025-05-28
00810031720019Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10810031720016Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive ControlLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative ControlLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17