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IMMULITE®/IMMULITE® 1000 Systems HCY Homocysteine

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE®/IMMULITE® 1000 Systems HCY Homocysteine FDA UDI
Generic Name
Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Homocystein - IMMULITE - RGT - 100 Tests FDA UDI
Model / Reference
10381029 FDA UDI
Description
Homocystein - IMMULITE - RGT - 100 Tests FDA UDI

Identifiers

Catalog Number
LKHO1 FDA UDI
Primary DI / UDI-DI
00630414964157 FDA UDI
510(k) Number
K003597 FDA UDI
FDA Product Code
LPS FDA UDI
GMDN Term
Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1377 FDA UDI
Commercial Distribution
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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Category: Homocysteine IVD, kit, chemiluminescent immunoassay

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Similar devices

Also classified as Homocysteine IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K003597 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI b9857ad4-3459-466d-8d5e-eac96aff3906 37 fields · synced Jul 23, 2026