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Bap1 (rbt-Bap1)

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
BAP1 (RBT-BAP1) FDA UDI
Generic Name
BRCA1 associated protein-1 (BAP-1) IVD, antibody FDA UDI
Device Name
BAP1 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-3839-1 FDA UDI
Description
BAP1 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-3839-1 FDA UDI
Primary DI / UDI-DI
B502BSB383910 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
BRCA1 associated protein-1 (BAP-1) 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 — 1 Milliliter FDA UDI

Category: BRCA1 associated protein-1 (BAP-1) IVD, antibody

Bap1 (rbt-Bap1) by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as BRCA1 associated protein-1 (BAP-1) 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 bd59c932-2723-4623-963a-f87db2f450d9 37 fields · synced May 30, 2026