Identity
- Trade Name
- FastPack® Pro System FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- RoHS Compliant 7-chamber FastPack System FDA UDI
- Model / Reference
- Pro System FDA UDI
- Description
- RoHS Compliant 7-chamber FastPack System FDA UDI
Identifiers
- Catalog Number
- 08000067, 08000067-R, 08000067-X FDA UDI
- Primary DI / UDI-DI
- 00816467020372 FDA UDI
- FDA Product Code
- JJQ FDA UDI
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2300 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chemiluminescent immunoassay analyser IVD
FastPack® Pro System by Qualigen Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Alinity — Abbott Laboratories, Inc. · N
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
- Qualigen Inc.
Sources (1)
- FDA UDI 5851e9ca-be6f-4193-96ce-bc1e228abb2e 35 fields · synced May 30, 2026