Identity
- Trade Name
- Optilite® Alpha-1-Antitrypsin Control Pack FDA UDI
- Generic Name
- Alpha-1-antitrypsin (protease inhibitor) IVD, control FDA UDI
- Model / Reference
- NQ034.OPT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700018999 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Alpha-1-antitrypsin (protease inhibitor) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Alpha-1-antitrypsin (protease inhibitor) IVD, control
Optilite® Alpha-1-Antitrypsin Control Pack by The Binding Site Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alpha-1-antitrypsin (protease inhibitor) IVD, control.
- A-1-Antitrypsin Control Slides — BIO SB, INC. · Class I
- A1AT CONTROLS (MM-MZ-MS) — Sebia, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI 10375411-ffeb-4085-95fb-170ce525cf33 34 fields · synced Jun 8, 2026