ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

Radioassay, Vitamin B12

Axis-Shield Diagnostics Ltd.

The following data is part of a premarket notification filed by Axis-shield Diagnostics Ltd. with the FDA for Advia Centaur Active-b12 (holotranscobalamin) (ab12) Assay.

Pre-market Notification Details

Device IDK172133
510k NumberK172133
Device Name:ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
ClassificationRadioassay, Vitamin B12
Applicant Axis-Shield Diagnostics Ltd. Luna Place The Technology Park Dundee,  GB Dd2 1xa
ContactClaire Dora
CorrespondentClaire Dora
Axis-Shield Diagnostics Ltd. Luna Place The Technology Park Dundee,  GB Dd2 1xa
Product CodeCDD  
CFR Regulation Number862.1810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-14
Decision Date2017-10-27
Summary:summary

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