Identity
- Trade Name
- Spartan RX CYP2C19 System FDA UDI
- Generic Name
- Nucleic acid amplification mastermix kit IVD FDA UDI
- Device Name
- A box of 10 CYP2C19 External Control Kits. FDA UDI
- Model / Reference
- 01004880-ABC (10) FDA UDI
- Description
- A box of 10 CYP2C19 External Control Kits. FDA UDI
Identifiers
- Catalog Number
- 01004880-ABC (10) FDA UDI
- Primary DI / UDI-DI
- 00628055420095 FDA UDI
- 510(k) Number
- K123891 FDA UDI
- FDA Product Code
- NSU FDA UDINTI FDA UDI
- GMDN Term
- Nucleic acid amplification mastermix kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI862.3360 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nucleic acid amplification mastermix kit IVD
Spartan RX CYP2C19 System by Spartan Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nucleic acid amplification mastermix kit IVD.
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Cleared under the same submission
K123891 also covers:
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc.
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc.
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc.
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc.
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc.
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc.
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc.
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc.
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
- Spartan Bioscience, Inc.
Sources (1)
- FDA UDI 16f574fc-31c4-44a7-86e0-e576bf6fa1b7 35 fields · synced Jun 1, 2026