Identity
- Trade Name
- FastPack® Control Kit FDA UDI
- Generic Name
- Multiple clinical chemistry enzyme IVD, control FDA UDI
- Device Name
- Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG FDA UDI
- Model / Reference
- Multi-Analyte Controls FDA UDI
- Description
- Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG FDA UDI
Identifiers
- Catalog Number
- 25000056 FDA UDI
- Primary DI / UDI-DI
- 00816467020136 FDA UDI
- 510(k) Number
- K123725 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple clinical chemistry enzyme 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
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
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: Multiple clinical chemistry enzyme IVD, control
FastPack® Control Kit by Qualigen Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 699d9a1e-dcc9-4a53-b7a1-4cd9317facb0 37 fields · synced Jun 8, 2026