FDA.report

Access Vitamin B12 Calibrator S0

Primary DI
15099590224318
Brand
Access Vitamin B12 Calibrator S0
Company
Beckman Coulter, Inc.
Model
33006
Catalog number
33006
Device description
The Access Vitamin B12 Calibrator S0 is intended for use with Access Vitamin B12 to dilute patient samples containing analyte concentrations greater t
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
CDDRadioassay, Vitamin B12

Product Code Classifications

CodeDeviceSpecialtyClass
CDDRadioassay, Vitamin B12Clinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590224318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959022431815099590224318

GMDN Terms

TermDefinition
Vitamin B12 IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of vitamin B12 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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