Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Multiple clinical chemistry enzyme IVD, control FDA UDI
- Device Name
- Chemistry Control Level 2 (5mL) FDA UDI
- Model / Reference
- CON 2-5U FDA UDI
- Description
- Chemistry Control Level 2 (5mL) FDA UDI
Identifiers
- Catalog Number
- CON 2-5U FDA UDI
- Primary DI / UDI-DI
- 00817274022368 FDA UDI
- 510(k) Number
- K981339 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
JAS Diagnostics by Drew Scientific , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K981339 also covers:
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
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 1f58e1eb-2ef7-406e-92d7-167f19cbffc8 37 fields · synced May 30, 2026