FDA.reportPublic FDA data

Fast PCR Base Station

Primary DI
00850025770002
Brand
Fast PCR Base Station
Company
Autonomous Medical Devices Incorporated
Model
FP-BS1
Catalog number
AMDI-0017
Device description
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.
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

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
00850025770002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025770002008500257700028500257700020850025770002

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
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
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
00850025770156Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 10)AMDI-00662026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025770026Fast PCR Operating ModuleAutonomous Medical Devices IncorporatedOOI2026-08-26
20816101029062LIAISON NES® Group A StrepDIASORIN MOLECULAR LLCOOI2026-07-23
20816101029079LIAISON NES® Group A Strep Control Swab KitDIASORIN MOLECULAR LLCOOI2026-07-23
06954414749823GN 7120 Akso PCR SystemGetein Biotech,IncOOI2026-07-10
06954414795394GN 7000 Akso PCR SystemGetein Biotech,IncOOI2026-07-10
00850028489017MyrnaInflammatix, Inc.OOI2026-04-30
00850028489024TriVerityInflammatix, Inc.OOI2026-04-30
00875197005240cobas® Cdiff TestRoche Molecular Systems, Inc.OOI2026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor KitRoche Molecular Systems, Inc.OOI2026-02-24
00875197005677cobas® CdiffRoche Molecular Systems, Inc.OOI2026-02-23
00875197005684cobas® Cdiff Control KitRoche Molecular Systems, Inc.OOI2026-02-23
10816101025142LIAISON NES® InstrumentDIASORIN MOLECULAR LLCOOI2026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCOOI2026-01-22
07332940009694GeneXpert®CEPHEIDOOI2026-01-19
07332940009700GeneXpert® XpressCEPHEIDOOI2026-01-19
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCOOI2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCOOI2026-01-14
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904448721BD Enteric Bacterial Panel plus for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904448738BD Enteric Bacterial Panel for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904452797Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
06955792701717Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2025-11-19
06955792701670Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2025-10-16
15420045517486Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517493Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517509Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517516Panther Fusion®Hologic, Inc.OOI2025-10-07
06955792700857Q-Vera Pico 6X qPCR InstrumentSansure Biotech Inc.OOI2025-09-18