FDA.reportPublic FDA data

Hemoglobin Capillary Collection System (HCCS)

Primary DI
00847817002731
Brand
Hemoglobin Capillary Collection System (HCCS)
Company
BIO-RAD LABORATORIES, INC.
Model
196-1054
Catalog number
1961054
Device description
Holder for manipulating the capillaries.
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection
LCPASSAY, GLYCOSYLATED HEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2
LCPAssay, Glycosylated HemoglobinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817002731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817002731008478170027318478170027310847817002731

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatographyA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen using a liquid chromatography method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4989318840info@bio-rad.com

Regulatory Flags#

DUNS number
132528295
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

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