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Simplexa™ Group A Strep Positive Control Pack

FDA UDI

Class II (US FDA UDI)

by DiaSorin Molecular LLC

Identity

Trade Name
Simplexa™ Group A Strep Positive Control Pack FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus nucleic acid IVD, control FDA UDI
Model / Reference
MOL2860 FDA UDI

Identifiers

Catalog Number
MOL2860 FDA UDI
Primary DI / UDI-DI
20816101025576 FDA UDI
510(k) Number
K143651 FDA UDI
FDA Product Code
PGX FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.2680 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

Yes

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

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 nucleic acid IVD, control

Simplexa™ Group A Strep Positive Control Pack by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-haemolytic Group A Streptococcus nucleic acid IVD, control.

Cleared under the same submission

K143651 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DiaSorin Molecular LLC

Sources (1)

  • FDA UDI 96d6dc4e-16f5-42d3-9ce0-12e782b05bfd 36 fields · synced Jun 9, 2026