Elecsys Anti-TSHR

Primary DI
07613336217641
Brand
Elecsys Anti-TSHR
Company
Roche Diagnostics GmbH
Model
09744819190
Catalog number
09744819190
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JZOSYSTEM, TEST, THYROID AUTOANTIBODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZOSystem, Test, Thyroid AutoantibodyImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193313000Elecsys Anti-TSHRRoche Diagnostics2020-02-27JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336217641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336217641076133362176417613336217641

GMDN Terms#

Term, Definition table
TermDefinition
Fibrin sealant biochemical preparation/application kit, open surgeryA collection of sterile devices designed to be used for the biochemical preparation and subsequent delivery of autologous fibrin sealant to a site of intervention during open surgery (e.g., to achieve haemostasis, seal air leaks, adhere tissues). It typically consists of a dedicated preparation unit (a cassette) with a collection of application devices including a spraypen applicator, needle, and tubing. Patient blood is contained within the preparation unit which is placed in a production unit (processor) which controls the biochemical processes and centrifugation to produce the fibrin sealant. This is a single-use device.

Regulatory Flags#

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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