FDA.reportPublic FDA data

Urisys 2400 Calibration strip

Primary DI
04015630004683
Brand
Urisys 2400 Calibration strip
Company
Roche Diagnostics GmbH
Model
3012590061
Catalog number
3012590061
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
JIOBLOOD, OCCULT, COLORIMETRIC, IN URINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIOBlood, Occult, Colorimetric, In UrineHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012397000URISYS 2400 URINE TEST STRIPRoche Diagnostics Corp.2001-09-26JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630004683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630004683040156300046834015630004683

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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