Tinto OCT4/POU5F1 (RBT-OCT4)

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: Tinto OCT4/POU5F1 (RBT-OCT4) FDA UDI
Generic Name: Oct-3/4 IVD, antibody FDA UDI
Device Name: Tinto OCT4/POU5F1 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Model / Reference: BSB-3830-7 FDA UDI
Description: Tinto OCT4/POU5F1 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI

Identifiers

Catalog Number: BSB-3830-7 FDA UDI
Primary DI / UDI-DI: B502BSB383070 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Oct-3/4 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 — 7 Milliliter FDA UDI

Category: Oct-3/4 IVD, antibody

Tinto OCT4/POU5F1 (RBT-OCT4) by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oct-3/4 IVD, antibody.

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OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
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OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
OCT 3/4 [N1NK] — 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: Bio Sb, Inc.

Sources (1)

FDA UDI 00ad26f8-a9c9-4171-b0f5-b3362dacca52 37 fields · synced May 30, 2026