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IMMULITE® Systems COR Calibration Verification Material Cortisol

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® Systems COR Calibration Verification Material Cortisol FDA UDI
Generic Name
Total cortisol IVD, control FDA UDI
Device Name
Cortisol Sample Diluent CVM - IMMULITE - CONS FDA UDI
Model / Reference
10487396 FDA UDI
Description
Cortisol Sample Diluent CVM - IMMULITE - CONS FDA UDI

Identifiers

Catalog Number
LCOCVM FDA UDI
Primary DI / UDI-DI
00630414977485 FDA UDI
510(k) Number
K141444 FDA UDI
FDA Product Code
LCP FDA UDI
GMDN Term
Total cortisol IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7470 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 cortisol IVD, control

IMMULITE® Systems COR Calibration Verification Material Cortisol by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Total cortisol IVD, control.

Cleared under the same submission

K141444 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 5bcafe41-037b-4884-8813-55f29a2d57f3 37 fields · synced May 31, 2026