SALL4 (6E3) Mouse Monoclonal Antibody

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 385M-17Model 385M-1X seriesRef 385M-16Ref 385M-14Ref 385M-15

by Cell Marque Corporation

Identity

Trade Name: SALL4 (6E3) Mouse Monoclonal Antibody EUDAMEDFDA UDI
Generic Name: Sal-like protein 4 (SALL4) IVD, antibody FDA UDI
Device Name: SALL4 (6E3) Mouse Monoclonal Antibody EUDAMED
Model / Reference: 385M-15 EUDAMEDFDA UDI
385M-16 EUDAMEDFDA UDI
385M-17 EUDAMEDFDA UDI
385M-14 EUDAMEDFDA UDI
385M-1X series EUDAMED

Identifiers

Primary DI / UDI-DI: 00841683140184 EUDAMEDFDA UDI
00841683140191 EUDAMEDFDA UDI
00841683140207 EUDAMEDFDA UDI
00841683140177 EUDAMEDFDA UDI
Basic UDI-DI: 008416831385M-1EB EUDAMED
FDA Product Code: NJT FDA UDI
EMDN Code: W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term: Sal-like protein 4 (SALL4) IVD, antibody FDA UDI

Classification

Device Class: Class C EUDAMED
Class I FDA UDI
Regulation Number: 864.1860 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

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: Sal-like protein 4 (SALL4) IVD, antibody

SALL4 (6E3) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Sal-like protein 4 (SALL4) IVD, antibody.

Mouse Monoclonal Anti-Human SALL4(MX128) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
SALL4 — BIOCARE MEDICAL, LLC · Class I
Mouse Monoclonal Anti-Human SALL4(MX128) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Anti-SALL4 — Biogenex Laboratories, Inc. · Class I
SALL4 — BIOCARE MEDICAL, LLC · Class I
Mouse Monoclonal Anti-Human SALL4(MX128) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Mouse Monoclonal Anti-Human SALL4(MX128) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
SALL4 — BIOCARE MEDICAL, LLC · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Cell Marque Corporation

Sources (8)

FDA UDI b2daa784-45ca-4077-a7aa-57797f9325f7 33 fields · synced Jul 24, 2026
FDA UDI ed812780-6f37-4060-96b3-17b4d1bba48f 33 fields · synced May 30, 2026
FDA UDI e4013950-24db-4c18-9c79-a58fd147a8cf 33 fields · synced May 30, 2026
FDA UDI 654d5363-8f07-4319-96a2-a3e1c0be0930 33 fields · synced May 30, 2026
EUDAMED 823bd5e6-a727-445f-a70b-a16dfe74ed9c 61 fields · synced Jul 10, 2026
EUDAMED fdb04532-ed8a-49cb-81ac-4c5cc3331f31 61 fields · synced Jul 11, 2026
EUDAMED 73f3d2ce-64a9-487b-95c5-9bd7d0cd7201 61 fields · synced Jul 14, 2026
EUDAMED fb53cb32-8c36-4382-8d46-7e53fe8ac8dc 61 fields · synced Jul 24, 2026