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Pastorex

FDA UDI

Class I (US FDA UDI)

by Bio-Rad

Identity

Trade Name
Pastorex FDA UDI
Generic Name
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
Device Name
Pastorex Staph-Plus FDA UDI
Model / Reference
56353 FDA UDI
Description
Pastorex Staph-Plus FDA UDI

Identifiers

Catalog Number
56353 FDA UDI
Primary DI / UDI-DI
03610520000953 FDA UDI
FDA Product Code
LHJ FDA UDI
GMDN Term
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

Pastorex by Bio-Rad — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Staphylococcus aureus culture isolate antigen IVD, kit, agglutination.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA UDI e80a9f6e-5a4e-42d7-aa10-d1d6ce86bc23 37 fields · synced May 30, 2026