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Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
Device Name
SP Staphslide LTX Test Determination FDA UDI
Model / Reference
B1077-15 FDA UDI
Description
SP Staphslide LTX Test Determination FDA UDI

Identifiers

Catalog Number
B1077-15 FDA UDI
Primary DI / UDI-DI
20885380020176 FDA UDI
FDA Product Code
JWX FDA UDI
GMDN Term
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

Yes

FDA UDI

Prescription Use

Yes

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

No

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

Cardinal Health by Cardinal Health 200, LLC — 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
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 1333c42a-0550-46fd-9c80-d6c8ae333615 35 fields · synced Jun 8, 2026