FDA.reportPublic FDA data

LIAISON 25 OH Vitamin D Total Assay 200 test

Primary DI
08056771602778
Brand
LIAISON 25 OH Vitamin D Total Assay 200 test
Company
Diasorin Inc.
Model
318360
Published
2021-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071480000LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602DiaSorin, Inc.2007-10-01MRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056771602775PackageGS110In Commercial Distribution
08056771602778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805677160277518056771602775
08056771602778080567716027788056771602778

GMDN Terms#

Term, Definition table
TermDefinition
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.

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
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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
08056771600064LIAISON® 25 OH Vitamin D TOTAL Assay3106002016-09-24