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IMMULITE® 2000 Systems SYP Syphilis Screen

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® 2000 Systems SYP Syphilis Screen FDA UDI
Generic Name
Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Syphilis - IMMULITE - RGT - 200 tests FDA UDI
Model / Reference
10471981 FDA UDI
Description
Syphilis - IMMULITE - RGT - 200 tests FDA UDI

Identifiers

Catalog Number
L2KSY2(D) FDA UDI
Primary DI / UDI-DI
00630414976891 FDA UDI
510(k) Number
K091361 FDA UDI
FDA Product Code
LIP FDA UDI
GMDN Term
Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3830 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: Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems SYP Syphilis Screen by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K091361 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 4495d12c-9e9e-47bc-9281-4e44a3346937 37 fields · synced May 30, 2026