Identity
- Trade Name
- IMUBIND PLASMA PAI-1 ELISA FDA UDI
- Generic Name
- Plasminogen activator inhibitor IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 822 FDA UDI
Identifiers
- Catalog Number
- 822 FDA UDI
- Primary DI / UDI-DI
- 00850201006048 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- Plasminogen activator inhibitor IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7290 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: Plasminogen activator inhibitor IVD, kit, enzyme immunoassay (EIA)
Imubind Plasma Pai-1 Elisa by Biomedica ADI Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Plasminogen activator inhibitor IVD, kit, enzyme immunoassay (EIA).
- SPECTROLYSE PAI-1 — Biomedica ADI 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomedica ADI Inc.
Sources (1)
- FDA UDI 1970272e-b574-4c99-b043-b22ff17f74da 33 fields · synced Jun 6, 2026