FDA.reportPublic FDA data

Complement Activation (CAE) Reagent Set

Primary DI
08056771600798
Brand
Complement Activation (CAE) Reagent Set
Company
Diasorin Inc.
Model
6100
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056771600798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771600798080567716007988056771600798

GMDN Terms#

Term, Definition table
TermDefinition
Total complement activity (CH50) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total complement activity (CH50 ) in a clinical specimen.

Contacts#

Phone, Email table
PhoneEmail
651-439-9710info@diasorin.com

Regulatory Flags#

DUNS number
033429783
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
08056771104418LIAISON QuantiFERON TB Gold Plus II3110852026-02-20
18056771104415LIAISON QuantiFERON TB Gold Plus II3110852026-02-20
08056771104470LIAISON Control QuantiFERON TB Gold Plus II3110812026-02-20
08056771104401LIAISON QuantiFERON TB Gold Plus II3110802026-02-19
08056771600811ANAFLUOR™16622016-09-24
08056771600828ANAFLUOR™16602016-09-24
08056771600835ANAFLUOR ™16242016-09-24
08056771600842ANAFLUOR™66242016-09-24
08056771600859ANAFAST™ ANA Fluorescent Test System 240 Wells16702016-09-24
08056771600897CT-3 Immunoscreen Fluoro-Kit™17402016-09-24
08056771600903CT-2 Immunoscreen Fluoro-Kit™17412016-09-24
08056771600910RS Fluoro-Kit™19702016-09-24
08056771600927ANAFLUOR™ Combo-Pak18122016-09-24
08056771600934ANA HEp-2 6-well Slide Pack16632016-09-24
08056771600941ANA HEp-2 12-well Slide Pack16612016-09-24
08056771600965CT-3 6-well Slide Pack18012016-09-24
08056771600972CT-2 Slide Pack16312016-09-24
08056771601030Fluorescent Antibody (HEp-2) Conjugate16642016-09-24
08056771600118LIAISON® Control HSV-2 IgG3106212016-09-24
08056771602778LIAISON 25 OH Vitamin D Total Assay 200 test3183602021-04-13