gudid
Primary ID: 78101
AIMSTRIP HEMOGLOBIN METER (UDI 78101)
Manufactured by GERMAINE LABORATORIES, INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AIMSTRIP HEMOGLOBIN METER - Primary ID 78101
Device Regulatory Overview
The AIMSTRIP HEMOGLOBIN METER (Model/Catalog Number: 78101) is a medical device manufactured by GERMAINE LABORATORIES, INC. This product is indexed under FDA Product Code / Category Classification GKR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 78101
- Product Code / EMDN
- GKR
- Device Name
- For the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA or sodium heparin. The testing system is designed for point-of-care use in primary care settings.
- Database Sync Date
- 2026-08-09 09:04:20
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 AIMSTRIP HEMOGLOBIN METER?
The registered manufacturer of record for AIMSTRIP HEMOGLOBIN METER is GERMAINE LABORATORIES, INC.
What is the Primary UDI-DI identifier for AIMSTRIP HEMOGLOBIN METER?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 78101.
What classification code is assigned to this device?
This device is registered under product classification code GKR.
Similar Classification Devices (GKR)
Other Devices by GERMAINE LABORATORIES, INC
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