Identity
- Trade Name
- PCT AccuLite CLIA Test System - 192 Wells FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 9275-300 FDA UDI
Identifiers
- Catalog Number
- 9275-300B FDA UDI
- Primary DI / UDI-DI
- 00816870023458 FDA UDI
- FDA Product Code
- NTM FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3210 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
Category: Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
PCT AccuLite CLIA Test System - 192 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Access PCT — Beckman Coulter, 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
- Monobind, Inc.
Sources (1)
- FDA UDI 8b0aa05b-38dc-43f1-921f-13d5b0c1e306 36 fields · synced May 30, 2026