AccessGUDID - DEVICE: LA 2 Confirmation Reagent (00842768007491)

GUDID

Device Identifier (DI) Information

Brand Name: LA 2 Confirmation Reagent
Version or Model: 10458687
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OQGR11
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768007491
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants

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?
56203	Lupus anticoagulant marker 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 qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GIR	REAGENT, RUSSEL VIPER VENOM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013114	000
K922156	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: c3f53382-85c2-4a3f-8aee-081e0ca39b39
Public Version Date: November 19, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2020