ihcDirect® Synaptophysin Ab Conjugate 15mL

FDA UDI

Class I (US FDA UDI)

by Novodiax, Inc.

Identity

Trade Name: ihcDirect® Synaptophysin Ab Conjugate 15mL FDA UDI
Generic Name: Synaptophysin IVD, antibody FDA UDI
Device Name: Clone R1003 FDA UDI
Model / Reference: H32034-R015 FDA UDI
Description: Clone R1003 FDA UDI

Identifiers

Catalog Number: K32034-015 FDA UDI
Primary DI / UDI-DI: 00850030934222 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Synaptophysin 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

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 — 15 Milliliter FDA UDI

Category: Synaptophysin IVD, antibody

ihcDirect® Synaptophysin Ab Conjugate 15mL by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synaptophysin IVD, antibody.

Synaptophysin Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
ANTI-SYNAPTOPHYSIN — Biogenex Laboratories, Inc. · Class I
Synaptophysin (EP158) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
Synaptophysin (EP158) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
Rabbit Monoclonal Anti-Human Synaptophysin Antibody, EP158 — EPITOMICS, INC. · Class I
Tinto Synaptophysin (RBT-Synaptophysin) — BIO SB, INC. · Class I
Mono Mo A-Hu Synaptophysin Cl DAK-SYNAP — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
ANTI-SYNAPTOPHYSIN — Biogenex Laboratories, 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

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

Manufacturer

Manufacturer: Novodiax, Inc.

Sources (1)

FDA UDI 2e599b83-e1ed-4956-b5cd-4f139b992c31 37 fields · synced May 30, 2026