Anti-Cd117/C-Kit/Scf

FDA UDI

Class I (US FDA UDI)

by Biogenex Laboratories, Inc.

Identity

Trade Name: ANTI-CD117/C-KIT/SCF FDA UDI
Generic Name: CD117 (c-kit) cell marker IVD, antibody FDA UDI
Model / Reference: PU759-UP FDA UDI

Identifiers

Catalog Number: PU759-UP FDA UDI
Primary DI / UDI-DI: 00810119677549 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: CD117 (c-kit) cell marker 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 — 1 Milliliter FDA UDI

Category: CD117 (c-kit) cell marker IVD, antibody

Anti-Cd117/C-Kit/Scf by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CD117 (c-kit) cell marker IVD, antibody.

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Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
Rabbit Monoclonal Anti-Human CD117(MXR037) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10 — EPITOMICS, INC. · Class I
CD117/c-kit — BIOCARE MEDICAL, LLC · Class I
Novocastra — Leica Biosystems Newcastle, Limited · Class I
CD117/c-kit — BIOCARE MEDICAL, LLC · 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: Biogenex Laboratories, Inc.

Sources (1)

FDA UDI 3d71aa6a-f2da-4736-9250-f1b751d9911e 36 fields · synced May 30, 2026