Identity
- Trade Name
- SeptiCyte RAPID FDA UDI
- Generic Name
- Reverse transcription reagent kit IVD FDA UDI
- Device Name
- US IVD Dispenser Box (to contain 6 cartridges, each within a pouch) FDA UDI
- Model / Reference
- SB3010U FDA UDI
- Description
- US IVD Dispenser Box (to contain 6 cartridges, each within a pouch) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10860007612616 FDA UDI
- 510(k) Number
- K203748 FDA UDI
- FDA Product Code
- PRE FDA UDI
- GMDN Term
- Reverse transcription reagent kit IVD 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
No
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 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.
- SeptiCyte RAPID — Immunexpress, Inc. · Class II
- SeptiCyte RAPID [US IVD] — Immunexpress, Inc. · Class II
- SeptiCyte RAPID [US IVD] — Immunexpress, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immunexpress, Inc.
Sources (1)
- FDA UDI 0649e8ce-237c-4f0e-b2b0-ac692184825c 34 fields · synced May 31, 2026