FDA.reportPublic FDA data

Alinity

Primary DI
00380740169916
Brand
Alinity
Company
ABBOTT IRELAND
Model
09P6324
Catalog number
09P6324
Device description
Immunoglobulin M 360 Tests
Published
2021-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DFTIGM, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFTIgm, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740169916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740169916003807401699163807401699160380740169916

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
989964119
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
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740169923ARCHITECTABBOTT IRELANDDFT2021-04-02
00380740175115ARCHITECTAbbott GmbHDFT2020-11-06
03610230007365Yumizen C1200 Immunoglobulin MHORIBA ABX SASDFT2020-07-13
00380740150693AlinityAbbott GmbHDFT2019-07-08
05055273204001IgMRANDOX LABORATORIES LIMITEDDFT2016-09-24
05055273204025IgMRANDOX LABORATORIES LIMITEDDFT2016-09-24
M52594000ImmunoFix ControlsHELENA LABORATORIES CORPORATIONDFT2016-09-07
00380740000202ARCHITECTABBOTT LABORATORIESDFT2016-06-06