Identity
- Trade Name
- POINTE SCIENTIFIC Albumin Standard FDA UDI
- Generic Name
- Albumin IVD, calibrator FDA UDI
- Device Name
- Intended for use as an albumin standard for standardization or calibration of bromocresol green (BCG) dye-binding albumin procedures. FDA UDI
- Model / Reference
- A7502-STD FDA UDI
- Description
- Intended for use as an albumin standard for standardization or calibration of bromocresol green (BCG) dye-binding albumin procedures. FDA UDI
Identifiers
- Catalog Number
- A7502-STD FDA UDI
- Primary DI / UDI-DI
- 00811727010049 FDA UDI
- 510(k) Number
- K822471 FDA UDI
- FDA Product Code
- CIX FDA UDI
- GMDN Term
- Albumin IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1035 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: Albumin IVD, calibrator
POINTE SCIENTIFIC Albumin Standard by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Albumin IVD, calibrator.
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Cleared under the same submission
K822471 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- Albumin (w/ssa#) — POINTE SCIENTIFIC, INC.
- Albumin (w/ssa#) — POINTE SCIENTIFIC, INC.
- Albumin Std (w/ssa#) — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC ALBUMIN — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC ALBUMIN — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC ALBUMIN — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Albumin — POINTE SCIENTIFIC, INC.
- Pointe Albumin Reagent — POINTE SCIENTIFIC, INC.
- Pointe Albumin on BS480 Analyzer — POINTE SCIENTIFIC, 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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 9919879c-f590-40f3-92d6-b694550b40c2 37 fields · synced May 31, 2026