Identity
- Trade Name
- HemosIL D-Dimer HS 500 FDA UDI
- Generic Name
- D-dimer IVD, kit, agglutination FDA UDI
- Device Name
- HemosIL D-Dimer HS 500 (XL) FDA UDI
- Model / Reference
- 0020500300 FDA UDI
- Description
- HemosIL D-Dimer HS 500 (XL) FDA UDI
Identifiers
- Catalog Number
- 00020500300 FDA UDI
- Primary DI / UDI-DI
- 08426951391615 FDA UDI
- FDA Product Code
- DAP FDA UDI
- GMDN Term
- D-dimer IVD, kit, agglutination 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
No
FDA UDI
Category: D-dimer IVD, kit, agglutination
HemosIL D-Dimer HS 500 by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as D-dimer IVD, kit, agglutination.
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- INNOVANCE D-Dimer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- D-Di Test® — DIAGNOSTICA STAGO, INC. · Class II
- STA® - Liatest® D-Di — DIAGNOSTICA STAGO, INC. · Class II
- INNOVANCE® D-Dimer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- DIMERTEST Latex assay — Biomedica ADI Inc. · Class II
- INNOVANCE® D-Dimer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI 597142b3-3259-43d3-aa91-389b0427d9e6 36 fields · synced Jun 6, 2026