Duns Number:528192913
Device Description: Glycohemoglobin Reagent Kit (HPLC, Standard Mode) 500 tests/boxThe glycohemoglobin reagen Glycohemoglobin Reagent Kit (HPLC, Standard Mode) 500 tests/boxThe 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 1×1800mL, Elution Buffer B 1×600mL, Hemolysis & Wash Buffer H 2×2000mL
Catalog Number
HP-L121
Brand Name
BioHermes Glycohemoglobin Reagent Kit (HPLC, Standard Mode)
Version/Model Number
BH-L01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
95f1c654-02ef-4a33-a1d2-b3ddbc36084c
Public Version Date
January 13, 2022
Public Version Number
1
DI Record Publish Date
January 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
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Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |