Anti-S100P

FDA UDI

Class I (US FDA UDI)

by Biogenex Laboratories, Inc.

Identity

Trade Name: Anti-S100P FDA UDI
Generic Name: S100 protein IVD, antibody FDA UDI
Model / Reference: AM993-10M FDA UDI

Identifiers

Catalog Number: AM993-10M FDA UDI
Primary DI / UDI-DI: 00810119678010 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: S100 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 — 10 Milliliter FDA UDI

Category: S100 protein IVD, antibody

Anti-S100P by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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S100P (RBT-S100P) — BIO SB, INC. · Class I
S100 beta (EP32) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
IHC — Slmp, LLC · Class I
Tinto S100A6 RMab — BIO SB, INC. · Class I
S100A9 RMab — BIO SB, 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: Biogenex Laboratories, Inc.

Sources (1)

FDA UDI 52fddba2-836d-4994-a036-00a697ec8605 36 fields · synced May 30, 2026