Human CD38 PE-Texas Red® Conjugate

FDA UDI

Class I (US FDA UDI)

by Life Technologies Limited

Identity

Trade Name: Human CD38 PE-Texas Red® Conjugate FDA UDI
Generic Name: CD38 cell marker IVD, antibody FDA UDI
Model / Reference: MHCD3817 FDA UDI

Identifiers

Primary DI / UDI-DI: 10190302011143 FDA UDI
FDA Product Code: MVU FDA UDI
GMDN Term: CD38 cell marker IVD, antibody FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4020 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

Yes

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

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Manufacturing Date

FDA UDI

Category: CD38 cell marker IVD, antibody

Human CD38 PE-Texas Red® Conjugate by Life Technologies Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CD38 cell marker IVD, antibody.

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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 (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: Life Technologies Limited

Sources (1)

FDA UDI 7467cae0-4112-4af2-9718-4bad39384303 32 fields · synced Jun 8, 2026