FDA.reportPublic FDA data

Immunoglobulin M

Primary DI
04015630913725
Brand
Immunoglobulin M
Company
Roche Diagnostics GmbH
Model
20737771322
Catalog number
20737771322
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
CFNMETHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982382000COBAS INTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.1998-09-28CFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630913725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630913725040156309137254015630913725

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using a nephelometry/turbidimetry method.

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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