Identity
- Trade Name
- ASiManager-AT FDA UDI
- Generic Name
- Microplate reader IVD, manual FDA UDI
- Device Name
- Semi-automated reader for RPR testomg FDA UDI
- Model / Reference
- NC-2400-0BT FDA UDI
- Description
- Semi-automated reader for RPR testomg FDA UDI
Identifiers
- Catalog Number
- NC-2400-0BT FDA UDI
- Primary DI / UDI-DI
- 00816057020041 FDA UDI
- FDA Product Code
- JQT FDA UDI
- GMDN Term
- Microplate reader IVD, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2400 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 1.24 Square meter FDA UDI
Category: Microplate reader IVD, manual
ASiManager-AT by Arlington Scientific, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI efcef82c-cac1-4bc9-ab2d-17bf3383baa6 37 fields · synced Jul 18, 2026