ihcDirect® Napsin A Ab-Enh 5mL

FDA UDI

Class I (US FDA UDI)

by Novodiax, Inc.

Identity

Trade Name: ihcDirect® Napsin A Ab-Enh 5mL FDA UDI
Generic Name: Napsin A IVD, antibody FDA UDI
Device Name: Clone R1010 FDA UDI
Model / Reference: K47043-005 FDA UDI
Description: Clone R1010 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850030934758 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Napsin A IVD, antibody FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 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

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

Dimensions & Sizes

Size: Total Volume — 5 Milliliter FDA UDI

Category: Napsin A IVD, antibody

ihcDirect® Napsin A Ab-Enh 5mL by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Napsin A IVD, antibody.

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Napsin A (RM) — BIOCARE MEDICAL, LLC · Class I
Napsin A Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
Tissue-Tek Genie® DUO — Sakura Finetek USA, Inc · Class I
Napsin A Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
Napsin A Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
Rabbit Monoclonal Anti-Human Napsin A Antibody, EP205 — 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: Novodiax, Inc.

Sources (1)

FDA UDI 3bcdd3d4-0b07-4010-8cb6-463af430f839 36 fields · synced May 30, 2026