Identity
- Trade Name
- Kova Plastics FDA UDI
- Generic Name
- Centrifuge tube IVD FDA UDI
- Device Name
- KOVA Plastics Urinalysis System EUDAMEDKova Plastics - Super System Pac 1000 with Grids (Urinalysis Kit Containing 1000 plastic tubes, 1000 plastic pipettes, 1000 plastic caps, and 100 10-chamber plastic slides with gridlines) FDA UDI
- Model / Reference
- 87163E EUDAMEDFDA UDI
- Description
- Kova Plastics - Super System Pac 1000 with Grids (Urinalysis Kit Containing 1000 plastic tubes, 1000 plastic pipettes, 1000 plastic caps, and 100 10-chamber plastic slides with gridlines) FDA UDI
Identifiers
- Catalog Number
- 87163E FDA UDI
- Primary DI / UDI-DI
- 00850033297218 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850033297KOVAPLASTICSF5 EUDAMED
- Direct Marketing DI
- 00850033297218 EUDAMED
- FDA Product Code
- NNW FDA UDI
- EMDN Code
- W05010202,W0503020199,W0503900202 EUDAMED
- GMDN Term
- Centrifuge tube IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
KOVA Plastics Urinalysis System by Alltrista Plastics LLC — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850033297KOVAPLASTICSF5 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Alltrista Plastics LLC
- EUDAMED SRN
- US-MF-000021674
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e2cac6db-7d45-4920-ab67-41f1d578ddcb 61 fields · synced Jun 19, 2026
- FDA UDI 307213fc-4091-4826-9294-43473fdadf61 36 fields · synced May 30, 2026