FDA.reportPublic FDA data

Alinity m

Primary DI
00884999048621
Brand
Alinity m
Company
ABBOTT MOLECULAR INC.
Model
09N15-085
Catalog number
09N15-085
Device description
Alinity m HR HPV CTRL Kit
Published
2024-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
P230003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230003000Alinity m HR HPVAbbott Molecular, Inc.2023-11-01MAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999048621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999048621008849990486218849990486210884999048621

GMDN Terms#

Term, Definition table
TermDefinition
Human papillomavirus (HPV) high-risk strain nucleic acid IVD, controlA material that is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple high-risk strains of human papillomavirus (HPV) associated with cervical cancer, which may include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and/or 68 in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
878263359
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884999051409simpli-COLLECT09N93-00109N93-0012025-06-26
30884999051349simpli-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
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
00382904429577BD Viper™ LT System PCR Tube/Tray KitBECTON, DICKINSON AND COMPANYMAQ2020-02-19