FDA.reportPublic FDA data

Alinity m

Primary DI
00884999048669
Brand
Alinity m
Company
ABBOTT MOLECULAR INC.
Model
09N17-03A
Catalog number
09N17-03A
Device description
Alinity m STI Application Specification File
Published
2022-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QEPNucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202977000Alinity m STI AssayAbbott Molecular, Inc.2022-04-29QEP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999048669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999048669008849990486698849990486690884999048669

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).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
878263359
Device count
1
DM exempt
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
00875197006056cobas® TV/MGRoche Molecular Systems, Inc.QEP2026-02-24
00875197006063cobas® TV/MG Positive Control KitRoche Molecular Systems, Inc.QEP2026-02-24
00875197006902cobas® TV/MGRoche Molecular Systems, Inc.QEP2026-02-24
00875197006919cobas® TV/MG Positive Control KitRoche Molecular Systems, Inc.QEP2026-02-24
00810031720125Visby Medical Men’s Sexual Health TestVisby Medical, Inc.QEP2025-10-23
00382904454357BD COR CTGCTV2 USBECTON, DICKINSON AND COMPANYQEP2025-10-21
05060441760050binx ioBINX HEALTH LIMITEDQEP2025-09-03
25060441760054binx ioBINX HEALTH LIMITEDQEP2025-09-03
00884999051096Alinity mABBOTT MOLECULAR INC.QEP2023-09-14
15420045514966APTIMAHologic, Inc.QEP2022-07-28
15420045514973APTIMAHologic, Inc.QEP2022-07-28
15420045514980APTIMAHologic, Inc.QEP2022-07-28
15420045514997APTIMAHologic, Inc.QEP2022-07-28
15420045515000APTIMAHologic, Inc.QEP2022-07-28
15420045515017APTIMAHologic, Inc.QEP2022-07-28
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYQEP2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYQEP2022-06-08
00884999048591Alinity mABBOTT MOLECULAR INC.QEP2022-05-19
00884999048607Alinity mABBOTT MOLECULAR INC.QEP2022-05-19
00884999048898Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
15420045512795APTIMAHologic, Inc.QEP2020-06-24
15420045512801APTIMAHologic, Inc.QEP2020-06-24
15420045512832Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045512849Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045512894Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045512900Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045509146Aptima®HOLOGIC LTD.QEP2019-01-25