FDA.reportPublic FDA data

cobas&#x00AE prime User Workflow Reagent Bottle

Primary DI
00875197006247
Brand
cobas&#x00AE prime User Workflow Reagent Bottle
Company
Roche Molecular Systems, Inc.
Model
08460426190
Catalog number
08460426190
Published
2020-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JQWSTATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197006247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197006247008751970062478751970062470875197006247

GMDN Terms#

Term, Definition table
TermDefinition
Assay container IVD, single-useA non-sterile reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071674100
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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