Axis-Shield Active-B12 (Holotranscobalamin) EIA FMABT100

GUDID 05055845400046

The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC)

AXIS-SHIELD DIAGNOSTICS LIMITED

Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent Vitamin B12 IVD, reagent
Primary Device ID05055845400046
NIH Device Record Key63f8bc2a-341b-4295-9462-346baec81c21
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxis-Shield Active-B12 (Holotranscobalamin) EIA
Version Model NumberFMABT100
Catalog NumberFMABT100
Company DUNS229062427
Company NameAXIS-SHIELD DIAGNOSTICS LIMITED
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441382422000
EmailMDL-AXD-Product-Support@alere.
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055845400046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDDRadioassay, Vitamin B12

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

Devices Manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED

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05055845400046 - Axis-Shield Active-B12 (Holotranscobalamin) EIA2018-07-06The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC)
05055845400046 - Axis-Shield Active-B12 (Holotranscobalamin) EIA2018-07-06 The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holot
05055845400084 - 3-Reagent Homocysteine Assay for SYNCHRON UniCel2018-07-06 The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total hom
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05055845400183 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in
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