Maternal Control - Level 2 (maternal Control 2)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: MATERNAL CONTROL - LEVEL 2 (MATERNAL CONTROL 2) FDA UDI
Generic Name: Trisomy 21-risk hormone IVD, control FDA UDI
Device Name: This product is intended for in vitro use in the quality control of Alpha-fetoprotein, Free Beta HCG, Free Estriol, Human Chorionic Gonadotrophin, Inhibin A and PAPP-A methods on clinical chemistry systems. FDA UDI
Model / Reference: MSS5025 FDA UDI
Description: This product is intended for in vitro use in the quality control of Alpha-fetoprotein, Free Beta HCG, Free Estriol, Human Chorionic Gonadotrophin, Inhibin A and PAPP-A methods on clinical chemistry systems. FDA UDI

Identifiers

Catalog Number: MSS5025 FDA UDI
Primary DI / UDI-DI: 05055273217582 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: Trisomy 21-risk hormone 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Trisomy 21-risk hormone IVD, control

Maternal Control - Level 2 (maternal Control 2) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Trisomy 21-risk hormone IVD, control.

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Monobind Qsure Maternal Control Set — MONOBIND, INC. · Class I
MATERNAL CONTROL - LEVEL 1 (MATERNAL CONTROL 1) — Randox Laboratories, Ltd. · Class I
MATERNAL CONTROL - LEVEL 3 (MATERNAL CONTROL 3) — Randox Laboratories, Ltd. · Class I

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

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Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI 91bb75f9-e4b6-4d34-b052-180f21020739 36 fields · synced May 31, 2026