FDA.reportPublic FDA data

Alinity m

Primary DI
00884999050594
Brand
Alinity m
Company
ABBOTT MOLECULAR INC.
Model
09N61-095
Catalog number
09N61-095
Device description
Alinity m HSV 1 & 2 / VZV AMP Kit
Published
2024-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGIHerpes virus (VZV, HSV1, HSV2), DNA detection assay for cutaneous and mucocutaneous lesion samples

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion SamplesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233349000Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.2024-05-03PGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999050594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999050594008849990505948849990505940884999050594

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple human herpesviruses in a clinical specimen, using a nucleic acid technique (NAT). Viruses detected may include (but not limited to) herpes simplex virus 1 (HSV1), herpes simplex virus 2 (HSV2) and/or varicella-zoster virus (VZV).

Storage And Handling#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999052062Alinity mABBOTT MOLECULAR INC.PGI2025-11-20
00884999050570Alinity mABBOTT MOLECULAR INC.PGI2024-07-26
00884999050587Alinity mABBOTT MOLECULAR INC.PGI2024-07-26
30014613340119SavannaDIAGNOSTIC HYBRIDS, INC.PGI2024-04-30
20816101025712Simplexa™ VZV Swab DirectDIASORIN MOLECULAR LLCPGI2019-12-13
00840733102158Alethia™ HSV 1&2 External Control KitMERIDIAN BIOSCIENCE, INC.PGI2019-01-09
00840733102219Alethia™ HSV 1&2MERIDIAN BIOSCIENCE, INC.PGI2019-01-09
03661540950025HSV 1&2 ELITe MGB AssayElitechgroup Mdx LLCPGI2018-12-14
30014613336105SolanaDIAGNOSTIC HYBRIDS, INC.PGI2018-08-07
00840733101151illumigene HSV 1&2 External Control KitMERIDIAN BIOSCIENCE, INC.PGI2016-09-23
00840733101182illumigene HSV 1&2MERIDIAN BIOSCIENCE, INC.PGI2016-09-23
30014613311027LyraQUIDEL CORPORATIONPGI2016-09-15
00840487100295ARIES® HSV 1&2 AssayLUMINEX CORPORATIONPGI2016-09-09