Identity
- Trade Name
- AGG/PAK 5 Combo Kit FDA UDI
- Generic Name
- Platelet aggregation study IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 107650 FDA UDI
Identifiers
- Catalog Number
- 107650 FDA UDI
- Primary DI / UDI-DI
- G0561076501 FDA UDI
- 510(k) Number
- K790769 FDA UDI
- FDA Product Code
- JOZ FDA UDI
- GMDN Term
- Platelet aggregation study IVD, kit, nephelometry/turbidimetry 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
Yes
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, kit, nephelometry/turbidimetry
AGG/PAK 5 Combo Kit by Bio/Data Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Platelet aggregation study IVD, kit, nephelometry/turbidimetry.
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- PAR/PAK II — Bio/Data Corp. · Class II
Cleared under the same submission
K790769 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio/Data Corp.
Sources (1)
- FDA UDI a1671efb-a46d-489c-af94-4a6623d1b9aa 34 fields · synced May 31, 2026