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IMMULITE/IMMULITE 1000 Systems ATG Anti-TG Ab

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE/IMMULITE 1000 Systems ATG Anti-TG Ab FDA UDI
Generic Name
Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
TG Ab - IMMULITE - RGT - 100 Tests FDA UDI
Model / Reference
10381641 FDA UDI
Description
TG Ab - IMMULITE - RGT - 100 Tests FDA UDI

Identifiers

Catalog Number
LKTG1 FDA UDI
Primary DI / UDI-DI
00630414964676 FDA UDI
510(k) Number
K980206 FDA UDI
FDA Product Code
JZO FDA UDI
GMDN Term
Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5870 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: Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

IMMULITE/IMMULITE 1000 Systems ATG Anti-TG Ab by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay.

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 26743bfc-afba-40ca-b8c2-4a040b3667df 37 fields · synced Jun 8, 2026