FDA.report

Access sTfR QC1

Primary DI
15099590210700
Brand
Access sTfR QC1
Company
Beckman Coulter, Inc.
Model
B11056
Catalog number
B11056
Device description
The Access sTfR QC1 is intended for monitoring system performance of the Access sTfR assay.
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590210700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959021070015099590210700

GMDN Terms

TermDefinition
Soluble transferrin receptor IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of soluble transferrin receptor in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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