FDA.reportPublic FDA data

Alinity m

Primary DI
00884999051928
Brand
Alinity m
Company
ABBOTT MOLECULAR INC.
Model
09N15-03C
Catalog number
09N15-03C
Device description
Alinity m HR HPV Application Specification File
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAQKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAQKit, Dna Detection, Human PapillomavirusUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230003014

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230003014Alinity m HR HPVAbbott Molecular, Inc.2023-11-01MAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999051928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999051928008849990519288849990519280884999051928

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-7042customerservice@abbottmolecular.com

Regulatory Flags#

DUNS number
878263359
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00884999051737RealTime09R20-00109R20-0012026-07-06
00884999051744Alinity m09R20-00209R20-0022026-07-06
00884999051287Alinity m09N15-03B09N15-03B2026-04-13
00884999051690simpli-COLLECT09R16-00109R16-0012026-04-13
00884999052062Alinity m09N61-03B09N61-03B2025-11-20
00884999047846Alinity m09N26-00109N26-0012020-04-29
00884999047853Alinity m09N26-00209N26-0022020-04-29
00884999047860Alinity m09N26-01009N26-0102020-04-29
00884999047426Alinity m09N26-01209N26-0122020-04-29
00884999047440Alinity m09N26-01409N26-0142020-04-29
00884999047464Alinity m09N26-01609N26-0162020-04-29
00884999047501Alinity m09N26-00409N26-0042020-04-29
00884999048096Alinity m09N26-01909N26-0192020-04-29
00884999048171Alinity m09N26-02009N26-0202020-04-29
00884999048034Alinity m08N53-00208N53-0022020-08-18
00884999031814m20009K15-019K15-012016-09-01
00884999049369Alinity m09N79-09509N79-0952025-06-27
00884999049376Alinity m09N79-08509N79-0852025-06-27
00884999049383Alinity m09N79-03A09N79-03A2025-06-27
00884999051348simpli-COLLECT09R02-00109R02-0012025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999051287Alinity mABBOTT MOLECULAR INC.MAQ2026-04-13
30382904454167BD Onclarity HPV Self Collection Diluent TubeBECTON, DICKINSON AND COMPANYMAQ2024-11-01
00382904454166BD Onclarity HPV Self Collection Diluent TubeBECTON, DICKINSON AND COMPANYMAQ2024-11-01
30382904454365BD Copan FLOQSwabs for HPV Self CollectionBECTON, DICKINSON AND COMPANYMAQ2024-10-09
00382904454364FLOQSwabs for HPV Self CollectionBECTON, DICKINSON AND COMPANYMAQ2024-10-09
30382904440726BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2024-09-13
00382904440725BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2024-09-13
30382904440740BD Onclarity™ HPV Extraction Reagent Trough for BD COR™BECTON, DICKINSON AND COMPANYMAQ2024-07-26
00382904440749BD Onclarity™ HPV Extraction Reagent Trough for BD COR™BECTON, DICKINSON AND COMPANYMAQ2024-07-26
00875197006896cobas HPV Positive Control KitRoche Molecular Systems, Inc.MAQ2024-06-06
00875197006889cobas HPVRoche Molecular Systems, Inc.MAQ2024-06-05
00382904440756BD Onclarity™ HPV Assay Reagent PackBECTON, DICKINSON AND COMPANYMAQ2024-04-29
30382904440832BD Onclarity™ HPV Assay Diluent for BD COR™BECTON, DICKINSON AND COMPANYMAQ2024-02-28
00382904440831BD Onclarity™ HPV Assay Diluent for BD COR™BECTON, DICKINSON AND COMPANYMAQ2024-02-28
00382904439880BD COR™ PX INSTRUMENTBECTON, DICKINSON AND COMPANYMAQ2024-02-16
00382904439903BD COR™ GX INSTRUMENTBECTON, DICKINSON AND COMPANYMAQ2024-02-16
00884999048614Alinity mABBOTT MOLECULAR INC.MAQ2024-01-02
00884999048621Alinity mABBOTT MOLECULAR INC.MAQ2024-01-02
00884999048676Alinity mABBOTT MOLECULAR INC.MAQ2024-01-02
30382904453283BD Onclarity™ HPV LBC Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2023-10-26
00382904453282BD Onclarity™ HPV LBC Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2023-10-26
30382904453290BD Onclarity™ HPV SurePath™ Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2023-10-25
00382904453299BD Onclarity™ HPV SurePath™ Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2023-10-25
00875197005752cobas HPV for use on the cobas 6800/8800 systemsRoche Molecular Systems, Inc.MAQ2021-06-04
00875197005769cobas HPV Positive ControlRoche Molecular Systems, Inc.MAQ2021-06-04
00382904419905BD Onclarity™ HPV Assay Reagent PackBECTON, DICKINSON AND COMPANYMAQ2021-04-19
00382904440886BD Control Set for the BD Onclarity™ HPV AssayBECTON, DICKINSON AND COMPANYMAQ2021-03-25
30382904438372BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2020-02-19
30382904440870BD Viper™ PCR Extraction Reagent Trough with Piecring ToolBECTON, DICKINSON AND COMPANYMAQ2020-02-19
30382904440894BD FOX™ PCR Extraction TubesBECTON, DICKINSON AND COMPANYMAQ2020-02-19