Anti-Human Progesterone Receptor

FDA UDI

Class I (US FDA UDI)

by Biogenex Laboratories, Inc.

Identity

Trade Name: ANTI-HUMAN PROGESTERONE RECEPTOR FDA UDI
Generic Name: Progesterone receptor IVD, antibody FDA UDI
Model / Reference: AY711-YCD FDA UDI

Identifiers

Catalog Number: AY711-YCD FDA UDI
Primary DI / UDI-DI: 00810119676627 FDA UDI
FDA Product Code: MVU FDA UDI
MXZ FDA UDI
GMDN Term: Progesterone receptor IVD, antibody FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4020 FDA UDI
864.1860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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: Progesterone receptor IVD, antibody

Anti-Human Progesterone Receptor by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Progesterone receptor IVD, antibody.

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Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody, EP2 — EPITOMICS, INC. · Class I
Genemed® — Sakura Finetek USA, Inc · Class I
QSX-Enh-P PR (ASR) — NOVODIAX, INC. · Class I
CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody — Ventana Medical Systems · Class II
Genemed® — Sakura Finetek USA, Inc · Class I
Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody, EP2 — EPITOMICS, INC. · Class I
Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody, EP2 — EPITOMICS, INC. · 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: Biogenex Laboratories, Inc.

Sources (1)

FDA UDI 4c150f78-f247-4857-9500-2e3f6ce8f692 35 fields · synced May 30, 2026