← Back to catalogue

IMMULITE® Systems TBG Calibration Verification Material TBG

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® Systems TBG Calibration Verification Material TBG FDA UDI
Generic Name
Thyroxine binding globulin (TBG) IVD, control FDA UDI
Device Name
TBG CVM - IMMULITE - CONS FDA UDI
Model / Reference
10373705 FDA UDI
Description
TBG CVM - IMMULITE - CONS FDA UDI

Identifiers

Catalog Number
LTBCVM FDA UDI
Primary DI / UDI-DI
00630414971377 FDA UDI
510(k) Number
K133124 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Thyroxine binding globulin (TBG) 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

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: Thyroxine binding globulin (TBG) IVD, control

IMMULITE® Systems TBG Calibration Verification Material TBG by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Thyroxine binding globulin (TBG) IVD, control.

Cleared under the same submission

K133124 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI e337ddc3-cc71-44bd-a877-3bcaef20b301 37 fields · synced May 30, 2026