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Tinto Toxoplasma gondii , RPab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Tinto Toxoplasma gondii ,RPab FDA UDI
Generic Name
Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control FDA UDI
Device Name
Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5 FDA UDI
Model / Reference
Predilute, 15 ml FDA UDI
Description
Tinto Toxoplasma gondii 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 6045 FDA UDI
Primary DI / UDI-DI
B502BSB60450 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

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

Similar devices

Also classified as Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control.

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 074053ef-1659-49a7-add2-fdf49afe79e9 34 fields · synced May 30, 2026