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Atellica IM Syph

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM Syph FDA UDI
Generic Name
Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Syphillis (Syph) Atellica IM - RGT 200T FDA UDI
Model / Reference
10995675 FDA UDI
Description
Syphillis (Syph) Atellica IM - RGT 200T FDA UDI

Identifiers

Catalog Number
10995675 FDA UDI
Primary DI / UDI-DI
00630414599885 FDA UDI
510(k) Number
K112343 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

No

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

Atellica IM Syph by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K112343 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI d9302bed-b7e8-45b0-881a-c9a8f006dd98 37 fields · synced Jun 8, 2026