AccessGUDID - DEVICE: Syva® Emit® LSD Control Level 2 (00842768002106)

GUDID

Device Identifier (DI) Information

Brand Name: Syva® Emit® LSD Control Level 2
Version or Model: 10445461
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9L519UL
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768002106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Syva® Emit® LSD Control Level 2

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?
55680	Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of lysergic acid diethylamide (LSD) and/or LSD metabolites in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DLB	RADIOIMMUNOASSAY, LSD (125-I)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955448	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 527d97a5-dd8a-40b2-8f42-97ea3f228d15
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016