FDA.reportPublic FDA data

Alinity

Primary DI
00380740138349
Brand
Alinity
Company
Abbott GmbH
Model
08P5021
Catalog number
08P5021
Device description
Alinity i HE4 Reagent Kit 200 Tests
Published
2019-01-03
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
OIUTest, epithelial ovarian tumor associated antigen (he4)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIUTest, Epithelial Ovarian Tumor Associated Antigen (He4)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093957000ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,Fujirebio Diagnostics,Inc.2010-03-18OIU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740138349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740138349003807401383493807401383490380740138349

GMDN Terms#

Term, Definition table
TermDefinition
Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human epididymis protein 4 (HE4) ovarian cancer marker in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
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
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630940219Elecsys HE4Roche Diagnostics GmbHOIU2017-04-14
04015630929641Elecsys HE4 AssayRoche Diagnostics GmbHOIU2016-09-20
17350066140326HE4 EIAFujirebio Diagnostics ABOIU2016-09-16
04987270234174Lumipulse G HE4 Immunoreaction CartridgesFUJIREBIO INC.OIU2016-09-16
00380740003975ARCHITECTAbbott GmbHOIU2016-06-06
00380740003982ARCHITECTAbbott GmbHOIU2016-06-06
00380740048433ARCHITECTAbbott GmbHOIU2016-06-06