Identity
- Trade Name
- iC-GN Assay FDA UDI
- Generic Name
- Multiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli. FDA UDI
- Model / Reference
- iCC-AAQA00000 FDA UDI
- Description
- The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B769ICCAAQA00000 FDA UDI
- 510(k) Number
- K190341 FDA UDI
- FDA Product Code
- PEN FDA UDI
- GMDN Term
- Multiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3365 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: Multiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
iC-GN Assay by Icubate, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icubate, Inc.
Sources (1)
- FDA UDI ebc00bb2-ee17-4320-856c-ea0579735099 36 fields · synced May 30, 2026