FDA.reportPublic FDA data

Alinity m

Primary DI
00884999047693
Brand
Alinity m
Company
ABBOTT MOLECULAR INC.
Model
09N20-002
Catalog number
09N20-002
Device description
Alinity m Ethanol Solution
Published
2022-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSLDNA-REAGENTS, NEISSERIA
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
OOIreal time Nucleic acid amplification system
OUYTrichomonas vaginalis nucleic acid amplification test system
QEPNucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test SystemImmunology2
QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999047693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999047693008849990476938849990476930884999047693

GMDN Terms#

Term, Definition table
TermDefinition
Molecular grade alcohol IVDA molecular grade alcohol solution intended to be used for the extraction of nucleic acids (e.g., DNA and/or RNA) from cells in a clinical specimen in preparation for further analysis using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
878263359
Device count
1
Kit
true
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

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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
00875197007251cobas® liat CT, NG and MG control kitRoche Molecular Systems, Inc.LSL2026-02-24
00875197007268cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.LSL2026-02-24
00875197007275cobas® liat CT/NGRoche Molecular Systems, Inc.LSL2026-02-24
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
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
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