FDA.reportPublic FDA data

Alinity m

Primary DI
00884999049482
Brand
Alinity m
Company
ABBOTT MOLECULAR INC.
Model
09N43-075
Catalog number
09N43-075
Device description
Alinity m EBV CTRL Kit
Published
2022-08-29
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
QLXNucleic acid amplification test for the quantitation of epstein-barr virus (EBV) DNA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLXNucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) DnaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212778000Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)Abbott Molecular, Inc.2022-07-15QLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999049482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999049482008849990494828849990494820884999049482

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) nucleic acid IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Epstein-Barr virus (EBV) 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

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
00884999051300Alinity mABBOTT MOLECULAR INC.QLX2024-01-31
00884999049499Alinity mABBOTT MOLECULAR INC.QLX2022-08-29
00884999049505Alinity mABBOTT MOLECULAR INC.QLX2022-08-29
00884999049697Alinity mABBOTT MOLECULAR INC.QLX2022-08-29
00875197006278cobas&#x00AE BKVRoche Molecular Systems, Inc.QLX2020-09-30
00875197006254cobas&#x00AE EBV/BKV Control KitRoche Molecular Systems, Inc.QLX2020-09-10
00875197006261cobas&#x00AE EBVRoche Molecular Systems, Inc.QLX2020-09-10