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Tinto IgG, RPab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Tinto IgG, RPab FDA UDI
Generic Name
Total immunoglobulin G (IgG total) IVD, antibody FDA UDI
Device Name
IgG is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5. FDA UDI
Model / Reference
Predilute, 1 ml FDA UDI
Description
IgG is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5. FDA UDI

Identifiers

Catalog Number
BSB 3074 FDA UDI
Primary DI / UDI-DI
B502BSB30740 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Total immunoglobulin G (IgG total) 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: Total immunoglobulin G (IgG total) IVD, antibody

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

Similar devices

Also classified as Total immunoglobulin G (IgG total) 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 f2c4f36e-6e21-4d17-9f5a-1dcf070adbab 34 fields · synced Jun 8, 2026