Anti-C-myc-Protein

FDA UDI

Class I (US FDA UDI)

by Biogenex Laboratories, Inc.

Identity

Trade Name: Anti-C-myc-Protein FDA UDI
Generic Name: c-MYC proto-oncogene protein IVD, antibody FDA UDI
Model / Reference: MU318-UC FDA UDI

Identifiers

Catalog Number: MU318-UC FDA UDI
Primary DI / UDI-DI: 00850646007501 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: c-MYC proto-oncogene protein 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: c-MYC proto-oncogene protein IVD, antibody

Anti-C-myc-Protein by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 2a670a63-29a4-4120-a412-3b1b22fb101c 36 fields · synced May 30, 2026