CD117/c-kit

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name: CD117/c-kit FDA UDI
Generic Name: CD117 (c-kit) cell marker IVD, antibody FDA UDI
Model / Reference: OPAI296T60 FDA UDI

Identifiers

Primary DI / UDI-DI: 00847627024565 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

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

FDA UDI

Manufacturing Date

FDA UDI

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

CD117/c-kit by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

PATHWAY Anti-c-KIT (9.7) Primary Antibody — Ventana Medical Systems · Class III
Human CD117 PE-Cy®5.5 Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
ANTI-CD117/C-KIT/SCF — Biogenex Laboratories, Inc. · Class I
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
Novocastra — Leica Biosystems Newcastle, Limited · Class I
ANTI-C-KIT/CD117 — Biogenex Laboratories, 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: Biocare Medical, Llc

Sources (1)

FDA UDI 2b232bbc-8cd9-4c73-8647-a718a66ca9e3 33 fields · synced May 31, 2026