← Back to catalogue

BioHermes Glycohemoglobin Reagent Kit (HPLC, Standard Mode)

FDA UDIEUDAMED
Ref HP-L222Model BH-L02Ref HP-L124Model BH-L01

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

Identity

Trade Name
BioHermes Glycohemoglobin Reagent Kit (HPLC, Standard Mode) FDA UDI
BioHermes Glycohemoglobin Reagent Kit (HPLC, Variant Mode) FDA UDI
Generic Name
Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
Device Name
Glycohemoglobin Reagent Kit (HPLC) EUDAMED
Glycohemoglobin Reagent Kit (HPLC, Standard Mode) 1000 tests/box The glycohemoglobin reagent kit (HPLC) is intended to be used with the BH60 Automated Glycohemoglobin Analyzer manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd., which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood. Contents: Elution Buffer A 2×1800mL, Elution Buffer B 1×1200mL, Hemolysis & Wash Buffer H 4×2000mL FDA UDI
Glycohemoglobin Reagent Kit (HPLC, Standard Mode) 3000 tests/box The glycohemoglobin reagent kit (HPLC) is intended to be used with the BH60 Automated Glycohemoglobin Analyzer manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd., which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood. Contents:Elution Buffer A 6×1800mL, Elution Buffer B 3×1200mL, Hemolysis & Wash Buffer H 12×2000 mL FDA UDI
Glycohemoglobin Reagent kit (HPLC, Variant Mode) 1000 tests/box The glycohemoglobin reagent kit (HPLC) is intended to be used with the BH60 Automated Glycohemoglobin Analyzer manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd., which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood. Contents:Elution Buffer A 2×1800mL, Elution Buffer B 1×1800mL, Hemolysis & Wash Buffer H 4×2000mL FDA UDI
Model / Reference
BH-L01 EUDAMEDFDA UDI
BH-L02 EUDAMEDFDA UDI
HP-L222 EUDAMED
HP-L124 EUDAMED
Description
Glycohemoglobin Reagent Kit (HPLC, Standard Mode) 1000 tests/box The glycohemoglobin reagent kit (HPLC) is intended to be used with the BH60 Automated Glycohemoglobin Analyzer manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd., which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood. Contents: Elution Buffer A 2×1800mL, Elution Buffer B 1×1200mL, Hemolysis & Wash Buffer H 4×2000mL FDA UDI
Glycohemoglobin Reagent Kit (HPLC, Standard Mode) 3000 tests/box The glycohemoglobin reagent kit (HPLC) is intended to be used with the BH60 Automated Glycohemoglobin Analyzer manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd., which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood. Contents:Elution Buffer A 6×1800mL, Elution Buffer B 3×1200mL, Hemolysis & Wash Buffer H 12×2000 mL FDA UDI
Glycohemoglobin Reagent kit (HPLC, Variant Mode) 1000 tests/box The glycohemoglobin reagent kit (HPLC) is intended to be used with the BH60 Automated Glycohemoglobin Analyzer manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd., which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood. Contents:Elution Buffer A 2×1800mL, Elution Buffer B 1×1800mL, Hemolysis & Wash Buffer H 4×2000mL FDA UDI

Identifiers

Catalog Number
HP-L122 FDA UDI
HP-L124 FDA UDI
HP-L222 FDA UDI
Primary DI / UDI-DI
06935784430245 EUDAMEDFDA UDI
06935784430320 EUDAMEDFDA UDI
06935784430221 FDA UDI
Basic UDI-DI
B-06935784430320 EUDAMED
B-06935784430245 EUDAMED
EMDN Code
W0101060107 HBA1C TEST STRIPS EUDAMED
GMDN Term
Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

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

Category: Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

BioHermes Glycohemoglobin Reagent Kit (HPLC, Standard Mode) by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (5)

  • FDA UDI d1f95696-e3e0-4bad-8883-d8cf9cc5af01 34 fields · synced Jul 28, 2026
  • FDA UDI 073d2858-d2b5-4cb0-9d55-c9a9360505d3 34 fields · synced May 30, 2026
  • FDA UDI a5d95029-1966-41a7-ae64-86680e7dbfb3 34 fields · synced May 30, 2026
  • EUDAMED cf9871b1-fc18-4290-8643-31f948a5317b 61 fields · synced Jul 22, 2026
  • EUDAMED 7c871272-6c51-462f-a299-fa8815592c87 61 fields · synced Jul 28, 2026