AccessGUDID - DEVICE: Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent (00842768030048)

GUDID

Device Identifier (DI) Information

Brand Name: Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent
Version or Model: 10488260
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8S079UL
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768030048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60457	Multiple immunosuppressant therapeutic drug monitoring IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of multiple immunosuppressant drugs which may include cyclosporin A (or cyclosporine), tacrolimus, sirolimus and/or everolimus, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRP	Sirolimus test system
MLM	ENZYME IMMUNOASSAY, TRACROLIMUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083487	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c146299c-a327-4025-ac9c-581c78225635
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016