Identity
- Trade Name
- Pointe Scientific, Inc. Urine Chemistry Controls FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- Pointe Scientific, Inc. Urine Chemistry Control Set is intended for use as a control for human urine assay methods. 6 x 10 ml. FDA UDI
- Model / Reference
- P7582-CTL FDA UDI
- Description
- Pointe Scientific, Inc. Urine Chemistry Control Set is intended for use as a control for human urine assay methods. 6 x 10 ml. FDA UDI
Identifiers
- Catalog Number
- P7582-CTL FDA UDI
- Primary DI / UDI-DI
- 00811727011930 FDA UDI
- 510(k) Number
- K831526 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Multiple urine analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: Multiple urine analyte IVD, control
Pointe Scientific, Inc. Urine Chemistry Controls by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, control.
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Cleared under the same submission
K831526 also covers:
- Pointe Scientific, Inc. Microalbumin Controls — POINTE SCIENTIFIC, INC.
- Dropper Urine Chemistry Control Level 1 Set 3x10mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 1 Set 3x25mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 1&2 Set 2x10mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 2 Set 3x10mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 2 Set 3x25mL — QUANTIMETRIX CORP.
- Microbumin Microalbumin Control Level 1&2 Set 10x7mL — QUANTIMETRIX CORP.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI fd3564b4-48df-45d7-9f2e-e743e003afdc 37 fields · synced May 30, 2026