Axis-Shield Active-B12 (Holotranscobalamin) EIA

FDA UDI

Class II (US FDA UDI)

by Axis-Shield Diagnostics Limited

Identity

Trade Name: Axis-Shield Active-B12 (Holotranscobalamin) EIA FDA UDI
Generic Name: Vitamin B12 IVD, reagent FDA UDI
Device Name: The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency. FDA UDI
Model / Reference: FMABT100 FDA UDI
Description: The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency. FDA UDI

Identifiers

Catalog Number: FMABT100 FDA UDI
Primary DI / UDI-DI: 05055845400046 FDA UDI
510(k) Number: K121946 FDA UDI
FDA Product Code: CDD FDA UDI
GMDN Term: Vitamin B12 IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Vitamin B12 IVD, reagent

Axis-Shield Active-B12 (Holotranscobalamin) EIA by Axis-Shield Diagnostics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Axis-Shield Diagnostics Limited

Sources (1)

FDA UDI 63f8bc2a-341b-4295-9462-346baec81c21 37 fields · synced May 30, 2026