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Tinto PMS2 (RBT-PMS2)

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Tinto PMS2 (RBT-PMS2) FDA UDI
Generic Name
Postmeiotic segregation increased 2 (PMS2) IVD, antibody FDA UDI
Device Name
Tinto PMS2 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-3832-7 FDA UDI
Description
Tinto PMS2 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-3832-7 FDA UDI
Primary DI / UDI-DI
B502BSB383270 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Postmeiotic segregation increased 2 (PMS2) 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 7 Milliliter FDA UDI

Category: Postmeiotic segregation increased 2 (PMS2) IVD, antibody

Tinto PMS2 (RBT-PMS2) by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Postmeiotic segregation increased 2 (PMS2) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio Sb, Inc.

Sources (1)

  • FDA UDI efaa81bb-5740-456a-a564-285c97b022b3 37 fields · synced Jun 6, 2026