FDA.reportPublic FDA data

Alinity m

Primary DI
00884999049314
Brand
Alinity m
Company
ABBOTT MOLECULAR INC.
Model
09N20-012
Catalog number
09N20-012
Device description
Alinity m Bottle for Ethanol Use
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
00884999049314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999049314008849990493148849990493140884999049314

GMDN Terms#

Term, Definition table
TermDefinition
Assay container IVD, single-useA reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

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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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
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