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IMMULITE® Systems SYP CONTROL Syphilis Screen

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® Systems SYP CONTROL Syphilis Screen FDA UDI
Generic Name
Treponema pallidum reagin antibody IVD, control FDA UDI
Device Name
Syphillis - IMMULITE - CTL - 2x6mL FDA UDI
Model / Reference
10469593 FDA UDI
Description
Syphillis - IMMULITE - CTL - 2x6mL FDA UDI

Identifiers

Catalog Number
LSYCM FDA UDI
Primary DI / UDI-DI
00630414976686 FDA UDI
510(k) Number
K091361 FDA UDI
FDA Product Code
LIP FDA UDI
GMDN Term
Treponema pallidum reagin antibody IVD, control 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 reagin antibody IVD, control

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

Similar devices

Also classified as Treponema pallidum reagin antibody IVD, control.

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 5b60ff60-9e43-4e94-802d-a967b1926f4e 37 fields · synced May 30, 2026