FDA.reportPublic FDA data

AutoDELFIA Inhibin A kit Level Calibrators

Primary DI
06438147344406
Brand
AutoDELFIA Inhibin A kit Level Calibrators
Company
Wallac Oy
Model
B064-112-P2
Catalog number
B064-112-P2
Device description
Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
Published
2018-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDREnzyme Immunoassay, Inhibin-A

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDREnzyme Immunoassay, Inhibin-AClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147344406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147344406064381473444066438147344406

GMDN Terms#

Term, Definition table
TermDefinition
Inhibin A IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative detection of inhibin A in a clinical specimen, using a fluorescent immunoassay method. Inhibin A detection is useful in studies of human reproductive physiology (e.g., as an endocrine marker for monitoring ovarian function).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-80 Degrees Celsius-60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438147332205chemagic Prepito -D2022-00202022-00202019-02-25
06438147356706chemagic 360-D2024-00102024-00102019-02-25
06438147371815Qsight 210 MD Screening System2040-00102040-00102023-03-29
06438147411672NeoLSD MSMS kit3093-004U3093-004U2025-08-15
06438147179596AutoDELFIA Neonatal hTSH kitB032-02CB032-02C2016-02-02
06438147179602AutoDELFIA Neonatal Thyroxine (T4) kitB065-01CB065-01C2016-02-02
06438147292479AutoDELFIA Neonatal 17α-OH-progesterone kitB024-01CB024-01C2018-11-16
06438147344420AutoDELFIA Inhibin A kit B064-112B064-1122017-10-10
06438147355037AutoDELFIA Unconjugated Estriol (uE3) kitB095-112B095-1122018-11-16
06438147377732Eonis SCID-SMA kit3241-001U3241-001U2022-11-30
06438147377756Eonis SCID-SMA kit3242-001U3242-001U2022-11-30
06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
06438147333219VICTOR EnLite1420-02301420-02302019-03-19
06438147064540Wallac Plate Shake1296-0041296-0042019-02-25
06438147009176DELFIA hCG kitA007-101A007-1012016-02-11
06438147009343AutoDELFIA hCG kitB007-112B007-1122016-02-11
06438147391998DBS Controls LysoPC3413-00103413-00102024-01-08
06438147392339LysoPC IS4417-00104417-00102024-01-08
06438147009336AutoDELFIA hCG kit B007-101B007-1012016-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842768026461Dimension Vista® Flex® reagent cartridge E2Siemens Healthcare Diagnostics Inc.NDR2020-09-24
00842768030314Dimension Vista® MULTI 1 SDILSiemens Healthcare Diagnostics Inc.NDR2020-09-24
06438147344420AutoDELFIA Inhibin A kit Wallac OyNDR2017-10-10
15099590180423Inhibin A ELISABeckman Coulter, Inc.NDR2016-09-09
15099590180430Inhibin A ELISABeckman Coulter, Inc.NDR2016-09-09
15099590203047Access Inhibin ABeckman Coulter, Inc.NDR2016-09-09