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Axis® Homocysteine EIA

FDA UDI

Class I (US FDA UDI)

by Axis-Shield Diagnostics Limited

Identity

Trade Name
Axis® Homocysteine EIA FDA UDI
Generic Name
Homocysteine IVD, reagent FDA UDI
Device Name
The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. FDA UDI
Model / Reference
FHCY100 FDA UDI
Description
The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. FDA UDI

Identifiers

Catalog Number
FHCY100 FDA UDI
Primary DI / UDI-DI
05055845400015 FDA UDI
510(k) Number
K980907 FDA UDI
FDA Product Code
JJX FDA UDI
LPS FDA UDI
DFC FDA UDI
GMDN Term
Homocysteine IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
862.1377 FDA UDI
866.5600 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Axis® Homocysteine EIA by Axis-Shield Diagnostics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K980907 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Axis-Shield Diagnostics Limited

Sources (1)

  • FDA UDI 7b9542d0-ee61-4f74-9296-75043b177572 38 fields · synced Jun 8, 2026