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BioHermes Glycohemoglobin Quality Control

FDA UDIEUDAMED
Ref A1C-C11Model A1C-GE C01Ref HP-C122Model BH-QC01Ref HP-C121

by Wuxi Biohermes Bio & Medical Technology Co., Ltd.

Identity

Trade Name
BioHermes Glycohemoglobin Quality Control FDA UDI
BioHermes Glycohemoglobin Quality Control (HPLC) FDA UDI
Generic Name
Glycated haemoglobin (HbA1c) IVD, control FDA UDI
Device Name
Glycohemoglobin Quality Control EUDAMED
Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (glycohemoglobin analyzers and test kits) with the methodology of boronate affinity chromatography, manufactured by Wuxi BioHermes Bio & Medical Technology Co.,Ltd.. Contents: Level 1: 5 vials x 50uL; Level 2: 5 vials x 50uL; Package Insert×1. FDA UDI
The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (the BH60 Automated Glycohemoglobin Analyzer and glycohemoglobin reagent kit) with the methodology of ion-exchange high-performance liquid chromatography (HPLC), manufactured by Wuxi BioHermes Bio & Medical Technology Co., Ltd.. Contents: 1 x Level 1 (1mL), 1 x Level 2 (1mL) FDA UDI
The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (the BH60 Automated Glycohemoglobin Analyzer and glycohemoglobin reagent kit) with the methodology of ion-exchange high-performance liquid chromatography (HPLC), manufactured by Wuxi BioHermes Bio & Medical Technology Co., Ltd.. Contents: 5 x Level 1 (1mL), 5 x Level 2 (1mL) FDA UDI
Model / Reference
A1C-GE C01 EUDAMEDFDA UDI
BH-QC01 EUDAMEDFDA UDI
A1C-C11 EUDAMED
HP-C122 EUDAMED
HP-C121 EUDAMED
Description
Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (glycohemoglobin analyzers and test kits) with the methodology of boronate affinity chromatography, manufactured by Wuxi BioHermes Bio & Medical Technology Co.,Ltd.. Contents: Level 1: 5 vials x 50uL; Level 2: 5 vials x 50uL; Package Insert×1. FDA UDI
The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (the BH60 Automated Glycohemoglobin Analyzer and glycohemoglobin reagent kit) with the methodology of ion-exchange high-performance liquid chromatography (HPLC), manufactured by Wuxi BioHermes Bio & Medical Technology Co., Ltd.. Contents: 1 x Level 1 (1mL), 1 x Level 2 (1mL) FDA UDI
The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (the BH60 Automated Glycohemoglobin Analyzer and glycohemoglobin reagent kit) with the methodology of ion-exchange high-performance liquid chromatography (HPLC), manufactured by Wuxi BioHermes Bio & Medical Technology Co., Ltd.. Contents: 5 x Level 1 (1mL), 5 x Level 2 (1mL) FDA UDI

Identifiers

Catalog Number
A1C-C12 FDA UDI
HP-C121 FDA UDI
HP-C122 FDA UDI
Primary DI / UDI-DI
06935784430412 EUDAMEDFDA UDI
06935784430429 EUDAMEDFDA UDI
06935784400095 EUDAMED
06935784420062 FDA UDI
Basic UDI-DI
B-06935784400095 EUDAMED
B-06935784430429 EUDAMED
B-06935784430412 EUDAMED
EMDN Code
W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
W0101050205 DIABETES CONTROLS EUDAMED
GMDN Term
Glycated haemoglobin (HbA1c) IVD, control FDA UDI

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Class IVD General EUDAMED
Market of Registration
Italy EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDIFDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMEDEUDAMED

Near-Patient Testing

Yes

EUDAMEDEUDAMED

Professional Testing

No

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Prescription Use

No

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

Yes

FDA UDI

BioHermes Glycohemoglobin Quality Control by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wuxi Biohermes Bio & Medical Technology Co., Ltd.

Sources (6)

  • FDA UDI bfff76f3-9d81-43ed-bb2c-d333bf0fb483 35 fields · synced Jul 11, 2026
  • FDA UDI 1559581f-090b-4918-a55c-727cd64a4b63 35 fields · synced May 29, 2026
  • FDA UDI f74fc349-462e-4cce-9f11-e43bdaf49bfb 35 fields · synced May 30, 2026
  • EUDAMED 7ce0da9d-9fd1-4015-bbed-9de8f3894a45 61 fields · synced Jul 9, 2026
  • EUDAMED dbbaf340-8b6d-457a-b7fa-57e8e8ba631b 61 fields · synced Jul 10, 2026
  • EUDAMED 0090b817-76e6-4e7b-a3e6-e3fca20bce96 61 fields · synced Jul 11, 2026