FLEX Mono Mo A-Hu Synaptophysin Cl DAK-SYNAP RTU (Link)

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name: FLEX Mono Mo A-Hu Synaptophysin Cl DAK-SYNAP RTU (Link) FDA UDI
Generic Name: Synaptophysin IVD, antibody FDA UDI
Device Name: FLEX Monoclonal Mouse Anti-Human Synaptophysin Clone DAK-SYNAP Ready-to-Use (Link) FDA UDI
Model / Reference: IR660 FDA UDI
Description: FLEX Monoclonal Mouse Anti-Human Synaptophysin Clone DAK-SYNAP Ready-to-Use (Link) FDA UDI

Identifiers

Primary DI / UDI-DI: 05700572034490 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

Category: Synaptophysin IVD, antibody

FLEX Mono Mo A-Hu Synaptophysin Cl DAK-SYNAP RTU (Link) by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID

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
ANTI-SYNAPTOPHYSIN — Biogenex Laboratories, Inc. · Class I
Synaptophysin (RBT-Synaptophysin) — BIO SB, 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: Agilent Technologies Singapore Pte Ltd

Sources (1)

FDA UDI a3d18de9-22c3-45a9-abc9-e7102edb9c60 36 fields · synced May 30, 2026