Identity
- Trade Name
- BUN/Polychem 180 FDA UDI
- Generic Name
- Urea IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- For the quantitative determination of urea nitrogen in serum using the Polychem 180 analyzer. For in vitro diagnostic use only. 6 x 51 ml, 4 x 20 ml FDA UDI
- Model / Reference
- BUN505 FDA UDI
- Description
- For the quantitative determination of urea nitrogen in serum using the Polychem 180 analyzer. For in vitro diagnostic use only. 6 x 51 ml, 4 x 20 ml FDA UDI
Identifiers
- Catalog Number
- BUN505 FDA UDI
- Primary DI / UDI-DI
- 00817439020291 FDA UDI
- 510(k) Number
- K972671 FDA UDI
- FDA Product Code
- CDQ FDA UDI
- GMDN Term
- Urea IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1770 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
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: Urea IVD, kit, enzyme spectrophotometry
BUN/Polychem 180 by Medtest DX — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Urea IVD, kit, enzyme spectrophotometry.
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Cleared under the same submission
K972671 also covers:
- BUN/BS200 — Medtest DX
- BUN/BS480 — Medtest DX
- POINTE SCIENTIFIC BUN — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC.
- Pointe BUN Reagent — POINTE SCIENTIFIC, INC.
- Pointe BUN on BS480 — POINTE SCIENTIFIC, INC.
- Pointe Scientific — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtest DX
Sources (1)
- FDA UDI 29e8fe4c-28a0-47fd-95d7-c3ca0deaca7a 37 fields · synced May 30, 2026