CD38 (SP149) Rabbit Monoclonal Antibody

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 118R-17Model 118R-1X seriesRef 118R-15Ref 118R-18

by Cell Marque Corporation

Identity

Trade Name: CD38 (SP149) Rabbit Monoclonal Antibody EUDAMEDFDA UDI
Generic Name: CD38 cell marker IVD, antibody FDA UDI
Device Name: CD38 (SP149) Rabbit Monoclonal Antibody EUDAMED
Model / Reference: 118R-17 EUDAMEDFDA UDI
118R-18 EUDAMEDFDA UDI
118R-15 EUDAMEDFDA UDI
118R-1X series EUDAMED
118R-14 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841683122289 EUDAMEDFDA UDI
00841683122296 EUDAMEDFDA UDI
00841683123828 EUDAMEDFDA UDI
00841683123811 FDA UDI
Basic UDI-DI: 008416831118R-1CJ EUDAMED
FDA Product Code: NJT FDA UDI
EMDN Code: W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term: CD38 cell marker 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: CD38 cell marker IVD, antibody

CD38 (SP149) Rabbit 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 CD38 cell marker IVD, antibody.

Rabbit Monoclonal Anti-Human CD38 Antibody, EP135 — EPITOMICS, INC. · Class I
ANTI-CD38 — Biogenex Laboratories, Inc. · Class I
Mono Mo A-Hu CD38/FITC Cl AT13/5 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
ANTI-CD38 — Biogenex Laboratories, Inc. · Class I
Rabbit Monoclonal Anti-Human CD38 Antibody, EP135 — EPITOMICS, INC. · Class I
Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
Mouse Monoclonal Anti-Human CD38(MX044) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Horizon — BECTON DICKINSON AND COMPANY · 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 (7)

FDA UDI 4f46fa91-d9d4-4df0-84d8-846bd4a3f2c0 33 fields · synced Jul 27, 2026
FDA UDI a2153aa1-fb7e-4662-ad57-72b6c6e20ba8 33 fields · synced May 30, 2026
FDA UDI 6151f352-3164-4900-aa5c-1287f6f106b7 33 fields · synced May 30, 2026
FDA UDI 9af8e589-d849-4e2e-8f1e-f996ecece15a 33 fields · synced May 30, 2026
EUDAMED eeb6d189-aab7-4e86-b1f3-c99823995191 61 fields · synced Jul 16, 2026
EUDAMED 70e7e0cc-1e0c-4d00-ad83-f0d69b59fff8 61 fields · synced Jul 21, 2026
EUDAMED 866c8c3e-6b43-40fb-bbee-cf1be1d2b23a 61 fields · synced Jul 27, 2026