Hemoglobin Capillary Collection System (HCCS) - For the collection of human whole blood for the - BIO-RAD LABORATORIES, INC.

Duns Number:132528295

Device Description: For the collection of human whole blood for the percent determination of hemoglobin A1c us For the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods

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More Product Details

Catalog Number

1962052

Brand Name

Hemoglobin Capillary Collection System (HCCS)

Version/Model Number

196-2052

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Device Record Status

Public Device Record Key

5a9b9d1c-2d3e-4555-b9bc-4a0b5bfc1fbe

Public Version Date

July 29, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO-RAD LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 511
2 A medical device with a moderate to high risk that requires special controls. 428
U Unclassified 1