Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Vancomycin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ARCHITECT iVancomycin Reagent Kit FDA UDI
- Model / Reference
- 1P30-28 FDA UDI
- Description
- ARCHITECT iVancomycin Reagent Kit FDA UDI
Identifiers
- Catalog Number
- 01P3028 FDA UDI
- Primary DI / UDI-DI
- 00380740105327 FDA UDI
- 510(k) Number
- K123947 FDA UDI
- FDA Product Code
- LEH FDA UDI
- GMDN Term
- Vancomycin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3950 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: Vancomycin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vancomycin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay.
Cleared under the same submission
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
- Abbott
Sources (1)
- FDA UDI 56fa6bc6-88d4-4caf-9223-9f6313503e22 37 fields · synced Jun 6, 2026