FDA.reportPublic FDA data

CoaguChek XS Patient Self Testing Care Kit

Primary DI
04015630945689
Brand
CoaguChek XS Patient Self Testing Care Kit
Company
Roche Diagnostics GmbH
Model
03666794001
Catalog number
03666794001
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GJSTest, Time, Prothrombin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJSTest, Time, ProthrombinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062925000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062925000COAGUCHEK XS SYSTEMRoche Diagnostics Corp.2007-01-29GJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630945689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630945689040156309456894015630945689

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 15-3 (CA15-3) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Serial number
true

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04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
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07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
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07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
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