Access 25(OH) Vitamin D Total A98856

GUDID 15099590226558

The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydrox

Beckman Coulter, Inc.

25-Hydroxy vitamin D2 IVD, reagent
Primary Device ID15099590226558
NIH Device Record Key43f710d7-b0c5-4bee-8b62-75f96c6db486
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess 25(OH) Vitamin D Total
Version Model NumberA98856
Catalog NumberA98856
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590226558 [Primary]

FDA Product Code

MRGSystem, Test, Vitamin D

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-04-09
Device Publish Date2016-09-09

On-Brand Devices [Access 25(OH) Vitamin D Total]

15099590226558The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay
15099590225964The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay
15099590744397The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay

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