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Parathyroid Hormone Control - Level 2 (pth Control 2)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref PTH10609

by Randox Laboratories Limited

Identity

Trade Name
PARATHYROID HORMONE CONTROL - LEVEL 2 (PTH CONTROL 2) EUDAMED
PTH CONTROL LEVEL 2 (PTH CONTROL 2) FDA UDI
Generic Name
Parathyroid hormone (PTH) IVD, control FDA UDI
Device Name
PTH CONTROL EUDAMED
The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyroid Hormone in human serum and plasma. The PTH Control Level 2 is assayed with target values and is suitable for use on many immunoassay analysers. The PTH Control Level 2 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI
Model / Reference
PTH10609 EUDAMEDFDA UDI
Description
The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyroid Hormone in human serum and plasma. The PTH Control Level 2 is assayed with target values and is suitable for use on many immunoassay analysers. The PTH Control Level 2 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI

Identifiers

Catalog Number
PTH10609 FDA UDI
Primary DI / UDI-DI
05055273219821 EUDAMEDFDA UDI
Basic UDI-DI
50552732BPTHSMT176XP EUDAMED
FDA Product Code
JJX FDA UDI
EMDN Code
W0102152002 HORMONE CONTROLS EUDAMED
GMDN Term
Parathyroid hormone (PTH) IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Northern Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Parathyroid Hormone Control - Level 2 (pth Control 2) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED b0f24532-1b5b-4c85-a68b-61cce98019e0 61 fields · synced Jun 19, 2026
  • FDA UDI 1d765396-fa49-448e-be00-4508ef735b90 36 fields · synced May 30, 2026