Identity
- Trade Name
- FastPack® IP System FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Model / Reference
- IP System FDA UDI
Identifiers
- Catalog Number
- 08000043-X2 FDA UDI
- Primary DI / UDI-DI
- 00816467020402 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® IP System by Qualigen Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chemiluminescent immunoassay analyser IVD.
- cobas e 801 Immunoassay analyzer — Roche Diagnostics Corp. · Class I
- ThunderBolt EIA (CLIA) — Gold Standard Diagnostics, LLC · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qualigen Inc.
Sources (1)
- FDA UDI 5052e0eb-ed39-4c8a-b391-ff7555f49dfe 34 fields · synced Jun 1, 2026