Identity
- Trade Name
- D-Dimer AccuLite CLIA Test System - 192 Wells FDA UDI
- Generic Name
- D-dimer IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 12075-300 FDA UDI
Identifiers
- Catalog Number
- 12075-300B FDA UDI
- Primary DI / UDI-DI
- 00816870023878 FDA UDI
- FDA Product Code
- DAP FDA UDI
- GMDN Term
- D-dimer IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7320 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: D-dimer IVD, kit, enzyme immunoassay (EIA)
D-Dimer AccuLite CLIA Test System - 192 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as D-dimer IVD, kit, enzyme immunoassay (EIA).
- VIDAS® D-Dimer Exclusion II ™ — BIOMERIEUX , INC. · Class II
- D-Dimer AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- D-Dimer AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- D-Dimer AccuLite CLIA Test System - 96 Wells — MONOBIND, 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 736693d7-4641-4e78-928f-0dd04b59d127 36 fields · synced May 30, 2026