FDA.reportPublic FDA data

Elecsys Myoglobin CalSet

Primary DI
04015630914449
Brand
Elecsys Myoglobin CalSet
Company
Roche Diagnostics GmbH
Model
12178222122
Catalog number
12178222122
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DDRMYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDRMyoglobin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083260000ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche Diagnostics2009-10-16DDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630914449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630914449040156309144494015630914449

GMDN Terms#

Term, Definition table
TermDefinition
Myoglobin IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of myoglobin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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