FDA.report

VARIANT II / VARIANT II TURBO

Primary DI
00847817012273
Brand
VARIANT II / VARIANT II TURBO
Company
BIO-RAD LABORATORIES, INC.
Model
270-2149
Catalog number
2702149
Device description
VARIANT II / VARIANT II TURBO Sample Vials
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LCPASSAY, GLYCOSYLATED HEMOGLOBIN

Product Code Classifications

CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847817012273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817012273008478170122738478170122730847817012273

GMDN Terms

TermDefinition
Glycated haemoglobin (HbA1c) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)224-6723diagcs@bio-rad.com

Regulatory Flags

DUNS number
132528295
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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