Identity
- Trade Name
- Aggreguide FDA UDI
- Generic Name
- Platelet aggregation study IVD, reagent FDA UDI
- Device Name
- AggreDYNE A-100 ADP Assay FDA UDI
- Model / Reference
- A-100 FDA UDI
- Description
- AggreDYNE A-100 ADP Assay FDA UDI
Identifiers
- Catalog Number
- 12020 FDA UDI
- Primary DI / UDI-DI
- 00856893004027 FDA UDI
- FDA Product Code
- JOZ FDA UDI
- GMDN Term
- Platelet aggregation study IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Platelet aggregation study IVD, reagent
Aggreguide by Aggredyne, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Platelet aggregation study IVD, reagent.
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- VerifyNow Platelet Reactivity Test — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Platelet Aggregation Kit — Helena Laboratories, Corp. · Class II
- ADP Reagent — Helena Laboratories, Corp. · Class II
- VerifyNow Platelet Reactivity Test — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- TEG HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION · 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
- Aggredyne, Inc.
Sources (1)
- FDA UDI ab4294f5-482d-40e9-a961-bc01bbed8b39 35 fields · synced May 29, 2026