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IMMULITE® Systems TIE Calibration Verification Material Total IgE

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® Systems TIE Calibration Verification Material Total IgE FDA UDI
Generic Name
Total immunoglobulin E (IgE total) IVD, control FDA UDI
Device Name
IgE Total CVM - IMMULITE - CONS FDA UDI
Model / Reference
10388001 FDA UDI
Description
IgE Total CVM - IMMULITE - CONS FDA UDI

Identifiers

Catalog Number
LIECVM FDA UDI
Primary DI / UDI-DI
00630414973692 FDA UDI
510(k) Number
K133122 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Total immunoglobulin E (IgE total) 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: Total immunoglobulin E (IgE total) IVD, control

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

Similar devices

Also classified as Total immunoglobulin E (IgE total) IVD, control.

Cleared under the same submission

K133122 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 154829a2-b456-405e-8237-b854ee2f6b17 37 fields · synced Jun 8, 2026