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AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 Wells
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 Wells FDA UDI
- Generic Name
- Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 8575-300 FDA UDI
Identifiers
- Catalog Number
- 8575-300D FDA UDI
- Primary DI / UDI-DI
- 00816870022550 FDA UDI
- FDA Product Code
- LOJ FDA UDI
- GMDN Term
- Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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
Yes
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 — 12 Inch FDA UDI
Category: Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay
AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay.
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 e488a71d-9d47-4d25-9981-070819d54982 36 fields · synced May 31, 2026