Identity
- Trade Name
- Pointe Scientific, Inc. Microprotein Standard FDA UDI
- Generic Name
- Total microprotein IVD, calibrator FDA UDI
- Device Name
- Pointe Scientific, Inc. Microprotein Standard is intended for use as a microprotein standard for standardization or calibration of pyragallol red microprotein procedures. 1 x 15 ml. FDA UDI
- Model / Reference
- P7582-STD FDA UDI
- Description
- Pointe Scientific, Inc. Microprotein Standard is intended for use as a microprotein standard for standardization or calibration of pyragallol red microprotein procedures. 1 x 15 ml. FDA UDI
Identifiers
- Catalog Number
- P7582-STD FDA UDI
- Primary DI / UDI-DI
- 00811727011923 FDA UDI
- 510(k) Number
- K070757 FDA UDI
- FDA Product Code
- JGP FDA UDI
- GMDN Term
- Total microprotein IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1635 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 microprotein IVD, calibrator
Pointe Scientific, Inc. Microprotein Standard by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 a1279c74-d6d4-481a-9742-84bd2e675961 37 fields · synced Jun 1, 2026