gudid
Primary ID: Z98
CarboFerm (UDI Z98)
Manufactured by HARDY DIAGNOSTICS
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CarboFerm - Primary ID Z98
Device Regulatory Overview
The CarboFerm (Model/Catalog Number: Z98) is a medical device manufactured by HARDY DIAGNOSTICS. This product is indexed under FDA Product Code / Category Classification LIB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Z98
- Product Code / EMDN
- LIB
- Device Name
- CarboFerm I, rapid carbohydrate test for Neisseria and Moraxella, 24 tests per kitFor the rapid identification and differentiation of Neisseria spp., including N. gonorrhoeae and N. meningitidis, and Moraxella (Branhamella) catarrhalis. CarboFerm uses acid production from carbohydrates to differentiate and identify Neisseria species and M. catarrhalis. Performs a glucose, lactose, maltose, sucrose, and butyrate test
- Database Sync Date
- 2026-08-09 09:31:30
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 CarboFerm?
The registered manufacturer of record for CarboFerm is HARDY DIAGNOSTICS.
What is the Primary UDI-DI identifier for CarboFerm?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z98.
What classification code is assigned to this device?
This device is registered under product classification code LIB.
Similar Classification Devices (LIB)
Other Devices by HARDY DIAGNOSTICS
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