Identity
- Trade Name
- Pointe Scientfic, Inc. FDA UDI
- Generic Name
- Total amylase IVD, kit, spectrophotometry FDA UDI
- Device Name
- Amylase EPS Reagent Set for the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only. Packaged at 12 x 22ml, 6 x 10ml FDA UDI
- Model / Reference
- HA965-324 FDA UDI
- Description
- Amylase EPS Reagent Set for the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only. Packaged at 12 x 22ml, 6 x 10ml FDA UDI
Identifiers
- Catalog Number
- HA965-324 FDA UDI
- Primary DI / UDI-DI
- 00811727012562 FDA UDI
- FDA Product Code
- CIJ FDA UDI
- GMDN Term
- Total amylase IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1070 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: Total amylase IVD, kit, spectrophotometry
Pointe Scientfic, Inc. by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total amylase IVD, kit, spectrophotometry.
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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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 80bc243b-52f9-4230-8a9d-82b9e72cd506 36 fields · synced May 30, 2026