gudid
Primary ID: C7563-30
Pointe Scientific CK-MB (UDI C7563-30)
Manufactured by HORIBA INSTRUMENTS INCORPORATED
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Pointe Scientific CK-MB - Primary ID C7563-30
Device Regulatory Overview
The Pointe Scientific CK-MB (Model/Catalog Number: C7563-30) is a medical device manufactured by HORIBA INSTRUMENTS INCORPORATED. This product is indexed under FDA Product Code / Category Classification JHW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- C7563-30
- Product Code / EMDN
- JHW
- Device Name
- Pointe Scientific Creatine Kinase-MB, 2-part liquid. 1x24 ml R1, 1x6 ml R2. For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and/or Automated Procedures. Rx Only.
- Database Sync Date
- 2026-08-09 09:22:13
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Pointe Scientific CK-MB?
The registered manufacturer of record for Pointe Scientific CK-MB is HORIBA INSTRUMENTS INCORPORATED.
What is the Primary UDI-DI identifier for Pointe Scientific CK-MB?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is C7563-30.
What classification code is assigned to this device?
This device is registered under product classification code JHW.
Similar Classification Devices (JHW)
Other Devices by HORIBA INSTRUMENTS INCORPORATED
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