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SeptiCyte RAPID [US IVD]

FDA UDI

Class II (US FDA UDI)

by Immunexpress, Inc.

Identity

Trade Name
SeptiCyte RAPID [US IVD] FDA UDI
Generic Name
Multiple clinical chemistry enzyme IVD, kit, enzyme fluorescence FDA UDI
Device Name
Sepsis Host Response US IVD EDTA PAXgene Variant Dispenser Box FDA UDI
Model / Reference
SB3020U FDA UDI
Description
Sepsis Host Response US IVD EDTA PAXgene Variant Dispenser Box FDA UDI

Identifiers

Primary DI / UDI-DI
10860007612654 FDA UDI
FDA Product Code
PRE FDA UDI
GMDN Term
Multiple clinical chemistry enzyme IVD, kit, enzyme fluorescence FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3215 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Reverse transcription reagent kit IVDMultiple clinical chemistry enzyme IVD, kit, enzyme fluorescence

SeptiCyte RAPID [US IVD] by Immunexpress, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry enzyme IVD, kit, enzyme fluorescence.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immunexpress, Inc.

Sources (1)

  • FDA UDI 52a1da07-7dcd-4005-8497-afd755cfa03a 33 fields · synced May 31, 2026