FDA.reportPublic FDA data

Fast PCR Mini Respiratory Panel Negative External Control Kits (5 Neg)

Primary DI
00850025770125
Brand
Fast PCR Mini Respiratory Panel Negative External Control Kits (5 Neg)
Company
Autonomous Medical Devices Incorporated
Model
AMDI-0063
Device description
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.
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
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) AssaysMicrobiology2

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
00850025770125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025770125008500257701258500257701250850025770125

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

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
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
00850025770033Fast PCR Mini Respiratory Panel Positive External ControlAutonomous Medical Devices IncorporatedPMN2026-08-26
00850025770040Fast PCR Mini Respiratory Panel Negative External ControlAutonomous Medical Devices IncorporatedPMN2026-08-26
00850025770057Fast PCR Mini Respiratory Panel External Control Kits (10 Pos + 10 Neg)Autonomous Medical Devices IncorporatedPMN2026-08-26
00850025770118Fast PCR Mini Respiratory Panel Positive External Control Kits (5 Pos)Autonomous Medical Devices IncorporatedPMN2026-08-26
00850025770132Fast PCR Mini Respiratory Panel External Control Kits, Small Format (5Pos+5Neg)Autonomous Medical Devices IncorporatedPMN2026-08-26
00852720008350FilmArray TF® Control Panel M527MmqciPMN2026-08-18
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00851458005310BioFire Warrior Panel Control KitBIOFIRE DEFENSE, LLCPMN2025-08-10
00852720008145SPOTFIRE RSP Pos & Neg ControlsMmqciPMN2025-06-18
00850063063012DASH® Negative Control Swabs KitNuclein, LLCPMN2025-01-06
00850063063029DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs KitNuclein, LLCPMN2025-01-06
15420045517059Aptima®Hologic, Inc.PMN2024-12-19
15420045517066Aptima®Hologic, Inc.PMN2024-12-19
30014613340485SavannaDIAGNOSTIC HYBRIDS, INC.PMN2024-04-30
30014613340492SavannaDIAGNOSTIC HYBRIDS, INC.PMN2024-04-30
00852720008091SPOTFIRE RSP Positive ControlMmqciPMN2023-09-15
00852720008107SPOTFIRE RSP Negative ControlMmqciPMN2023-09-15
00851458005273BioFire® Global Fever Special Pathogens PanelBIOFIRE DEFENSE, LLCPMN2023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneBIOFIRE DEFENSE, LLCPMN2023-08-31
00844509002437MDx-Chex for BC-GNSTRECK, INC.PMN2023-08-09
00844509002468MDx-Chex for BC-GPSTRECK, INC.PMN2023-08-09
00852720008121BioFire JI Control Panel M420MmqciPMN2022-11-14
01220000260238NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
01220000260245NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
01220000260252NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
00844509002338MDx-Chex for BCID2STRECK, INC.PMN2022-01-25
00852720008114BioFire RP2.1/RP2.1plus Control Panel M441MmqciPMN2021-09-16
00851458005259BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel BIOFIRE DEFENSE, LLCPMN2021-07-16
00852720008077FilmArray BCID2 Control Panel M416MmqciPMN2021-02-18
00852720008053FilmArray Warrior Control Panel M290MmqciPMN2020-11-24