Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Beta-hydroxybutyrate dehydrogenase IVD, control FDA UDI
- Device Name
- Set for use as controls in quantitative procedures for Acetaminophen, Salicylate and b-hydroxybutyrate. 6 x 5ml FDA UDI
- Model / Reference
- H7587-CTL FDA UDI
- Description
- Set for use as controls in quantitative procedures for Acetaminophen, Salicylate and b-hydroxybutyrate. 6 x 5ml FDA UDI
Identifiers
- Catalog Number
- H7587-CTL FDA UDI
- Primary DI / UDI-DI
- 00811727011572 FDA UDI
- 510(k) Number
- K910108 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Beta-hydroxybutyrate dehydrogenase IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1435 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: Beta-hydroxybutyrate dehydrogenase IVD, control
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K910108 also covers:
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 0aabc952-ca93-4e56-a8a1-eef0fb61cd9d 37 fields · synced May 30, 2026