IMMULITE® Systems TAD CONTROL Thyroid Autoantibody

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: IMMULITE® Systems TAD CONTROL Thyroid Autoantibody FDA UDI
Generic Name: Thyroglobulin IVD, control FDA UDI
Device Name: Thyroid Autoab - IMMULITE - CTL - 2x5mL FDA UDI
Model / Reference: 10385381 FDA UDI
Description: Thyroid Autoab - IMMULITE - CTL - 2x5mL FDA UDI

Identifiers

Catalog Number: LAACM FDA UDI
Primary DI / UDI-DI: 00630414953335 FDA UDI
510(k) Number: K971051 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Thyroglobulin IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Thyroglobulin IVD, control

IMMULITE® Systems TAD CONTROL Thyroid Autoantibody by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Thyroglobulin IVD, control.

VALIDATE THY2 — LGC Clinical Diagnostics, Inc. · Class I
Thyroglobulin Control Slides — BIO SB, INC. · Class I
Validate — LGC Clinical Diagnostics, Inc. · Class I
Thyroglobulin Control Slides — BIO SB, INC. · Class I
Thyroglobulin Control Slides — BIO SB, INC. · Class I
Tg II CalCheck 5 — Roche Diagnostics Corp. · Class I
IMMULITE® Systems TG CONTROL Thyroglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Atellica IM Thyroglobulin (Tg) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI 7dbaea8c-b0c4-41b8-bb50-610dfc684448 37 fields · synced Jun 8, 2026