Duns Number:528192913
Device Description: BH60 Glycohemoglobin Reorder Pack (HPLC, Variant Mode) 3000 tests/boxBH60 Glycohemoglobi BH60 Glycohemoglobin Reorder Pack (HPLC, Variant Mode) 3000 tests/boxBH60 Glycohemoglobin Reorder Pack (HPLC, Variant Mode) 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 3×1800mL, Hemolysis & Wash Buffer H 12×2000 mL, Column 1x 3000 tests.
Catalog Number
HP-P224
Brand Name
BH60 Glycohemoglobin Reorder Pack (HPLC, Variant Mode)
Version/Model Number
BH-P02
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)
-
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
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
05446550-0013-4d1e-aa99-4d2aa26408b8
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
-
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 |