← Back to catalogue

Toxoplasma gondii RPab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Toxoplasma gondii RPab FDA UDI
Generic Name
Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control FDA UDI
Device Name
Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5 FDA UDI
Model / Reference
Concentrate, 1 ml FDA UDI
Description
Anti-Toxoplasma 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 6048 FDA UDI
Primary DI / UDI-DI
B502BSB60480 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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio Sb, Inc.

Sources (1)

  • FDA UDI 2d971dba-162d-4d79-ab62-c69afa53e585 34 fields · synced May 30, 2026