Identity
- Trade Name
- Inorganic Phosphorous (IP) Test Kit (Phosphomolybdate) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Inorganic phosphate (PO43-) IVD, reagent FDA UDI
- Device Name
- Inorganic Phosphorous (IP) Test Kit (Phosphomolybdate) EUDAMED
- Model / Reference
- R:60mL×2（701） EUDAMEDR:60mL×2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674865049 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674865049 EUDAMED
- FDA Product Code
- CEO FDA UDI
- EMDN Code
- W01010307 PHOSPHATE INORGANIC / PHOSPHORUS EUDAMED
- GMDN Term
- Inorganic phosphate (PO43-) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1580 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inorganic phosphate (PO43-) IVD, reagent
Biobase by Biobase Biodustry(Shandong)Co., Ltd. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Inorganic phosphate (PO43-) IVD, reagent.
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- Alinity — Abbott · Class I
- Fosforo UV — GIESSE DIAGNOSTICS SRL · IVD General
- OS-PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
- Phosphorus Kit (Phosphomolybdate Method) — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IVD General
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong)Co., Ltd.
Sources (2)
- FDA UDI 22a93c6c-73eb-4eb4-8a01-e4c337ee5c0e 32 fields · synced Sep 18, 2026
- EUDAMED c18cf344-cce4-463f-84fd-5dce7cf22f91 61 fields · synced Sep 18, 2026