← Back to catalogue

McKesson

FDA UDI

Class I (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name
McKesson FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Status Strep A Flip FDA UDI
Model / Reference
181-34125 FDA UDI
Description
Status Strep A Flip FDA UDI

Identifiers

Primary DI / UDI-DI
00612479242869 FDA UDI
FDA Product Code
GTY FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3740 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

McKesson's Status Strep A Flip is a rapid, in-use (IUU) test for the qualitative detection of Group A beta-haemolytic Streptococcus bacteria in clinical specimens using an immunochromatographic test (ICT) method. It is not intended for self-testing and should only be used by healthcare professionals in their clinical practice.

Similar devices

Also classified as Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical.

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
Mckesson Medical-Surgical Inc.

Sources (1)

  • FDA UDI 798119cf-69fb-488d-badb-69081aefa097 33 fields · synced Jul 17, 2026