IDS-iSYS 17-OH Progesterone Control Set

FDA UDI

Class I (US FDA UDI)

by Immunodiagnostic Systems , Ltd.

Identity

Trade Name: IDS-iSYS 17-OH Progesterone Control Set FDA UDI
Generic Name: Progesterone IVD, control FDA UDI
Model / Reference: IS-5130 FDA UDI

Identifiers

Primary DI / UDI-DI: 05060169690882 FDA UDI
510(k) Number: K161082 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Progesterone 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Progesterone IVD, control

IDS-iSYS 17-OH Progesterone Control Set by Immunodiagnostic Systems , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Progesterone IVD, control.

Atellica IM PRGE MCM — Siemens Healthcare Diagnostics · Class I
IMMULITE® Systems PRG Calibration Verification Material Progesterone — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Alinity — ABBOTT IRELAND · Class I
ARCHITECT — ABBOTT IRELAND · Class II
LIAISON® Progesterone II Gen Control Set — Diasorin Inc.
ADVIA Centaur® Immunoassay Systems PRGE MCM — Siemens Healthcare Diagnostics · Class I
VALIDATE — LGC Clinical Diagnostics, Inc. · Class I

Cleared under the same submission

K161082 also covers:

IDS-iSYS 17-OH Progesterone Calibration Verifiers — Immunodiagnostic Systems , Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Immunodiagnostic Systems , Ltd.

Sources (1)

FDA UDI 01eb4faa-c4b6-4c04-9d79-59475d1c1e88 35 fields · synced May 30, 2026