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Tinto A-1-Antichymotrypsin RPab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Tinto A-1-Antichymotrypsin RPab FDA UDI
Generic Name
Alpha-1-antichymotrypsin IVD, antibody FDA UDI
Device Name
A-1-Antichymotrypsin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in bufferpH 7.5, FDA UDI
Model / Reference
Predilute, 3 ml FDA UDI
Description
A-1-Antichymotrypsin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in bufferpH 7.5, FDA UDI

Identifiers

Catalog Number
BSB5001 FDA UDI
Primary DI / UDI-DI
B502BSB50010 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Alpha-1-antichymotrypsin 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Alpha-1-antichymotrypsin IVD, antibody

Tinto A-1-Antichymotrypsin RPab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alpha-1-antichymotrypsin 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 003b34be-3bd0-4dee-8f04-87250f3c21d5 34 fields · synced May 30, 2026