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AIA-PACK 27.29 Sample Diluting Solution
FDA UDIClass II (US FDA UDI)
by Tosoh Corp.
Identity
- Trade Name
- AIA-PACK 27.29 Sample Diluting Solution FDA UDI
- Generic Name
- Cancer antigen 15-3 (CA15-3) IVD, reagent FDA UDI
- Model / Reference
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211094 FDA UDI
- FDA Product Code
- MOI FDA UDI
- GMDN Term
- Cancer antigen 15-3 (CA15-3) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cancer antigen 15-3 (CA15-3) IVD, reagent
AIA-PACK 27.29 Sample Diluting Solution by Tosoh Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Tosoh Corp.
Sources (1)
- FDA UDI f5a2c5af-e8ab-41eb-bd67-be46269ec94e 34 fields · synced May 31, 2026