Myogenin

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name: Myogenin FDA UDI
Generic Name: Myogenin IVD, antibody FDA UDI
Model / Reference: PM115AA FDA UDI

Identifiers

Primary DI / UDI-DI: 00847627011060 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Myogenin 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: Myogenin IVD, antibody

Myogenin by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Tinto Myogenin, RMab — BIO SB, INC. · Class I
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Myogenin (F5D) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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 23a60d1c-60a5-4cae-b7fd-e7c72310117b 33 fields · synced Jun 1, 2026