← Back to catalogue

IMMULITE® Systems DPD Calibration Verification Material Pyrilinks-D

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® Systems DPD Calibration Verification Material Pyrilinks-D FDA UDI
Generic Name
Cyclic adenosine monophosphate (cAMP) IVD, control FDA UDI
Device Name
Pyrilinks-D CVM - IMMULITE - CONS FDA UDI
Model / Reference
10373700 FDA UDI
Description
Pyrilinks-D CVM - IMMULITE - CONS FDA UDI

Identifiers

Catalog Number
LPDCVM FDA UDI
Primary DI / UDI-DI
00630414971322 FDA UDI
510(k) Number
K133128 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Cyclic adenosine monophosphate (cAMP) 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: Cyclic adenosine monophosphate (cAMP) IVD, control

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

Cleared under the same submission

K133128 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 23db52e8-0f40-4965-96f5-1813509f7be8 37 fields · synced May 30, 2026