Identity
- Trade Name
- i-STAT FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
- Device Name
- i-Stat 1 Wireless Analyzer FDA UDI
- Model / Reference
- 03P75-51 FDA UDI
- Description
- i-Stat 1 Wireless Analyzer FDA UDI
Identifiers
- Catalog Number
- 03P75-51 FDA UDI
- Primary DI / UDI-DI
- 00054749003365 FDA UDI
- 510(k) Number
- K103195 FDA UDI
- FDA Product Code
- CGA FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple clinical chemistry analyser IVD, point-of-care
i-STAT by Abbott Point of Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CardioChek — HENRY SCHEIN, INC. · Class I
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Cleared under the same submission
K103195 also covers:
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care Inc.
- i-STAT — Abbott Point of Care 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 |
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Manufacturer
- Manufacturer
- Abbott Point of Care Inc.
Sources (1)
- FDA UDI 67e36c44-3e4c-4b41-a7b1-18c1118e1da6 37 fields · synced Jun 9, 2026