AccessGUDID - DEVICE: LeadCare® II Blood Lead Testing System 9X Test Kit (00850355006093)

GUDID

Device Identifier (DI) Information

Brand Name: LeadCare® II Blood Lead Testing System 9X Test Kit
Version or Model: LeadCare® II
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-9000
Company Name: MAGELLAN DIAGNOSTICS, INC.

Primary DI Number: 00850355006093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078525694 *Terms of Use

Device Description: LeadCare® II Blood Lead Testing System 9X Test Kit

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
31646	Lead (Pb) analyser IVD	An electrically-powered laboratory instrument intended to be used for the quantitative determination of the heavy metal lead (Pb) in a clinical specimen, using technology which may incorporate fluorometry or electrometry. The analyser requires the use of specific reagents and test strips, packaged together in a test kit. The analyser is intended to be used by health professionals at the point-of-care, and often also in the laboratory.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DOF	Lead, Atomic Absorption

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052549	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
Special Storage Condition, Specify: Keep sensors sealed in their container until the sample is prepared and you are ready to perform the test. The container is lined with desiccant to keep the sensors fresh.
Special Storage Condition, Specify: Store away from direct sunlight.
Special Storage Condition, Specify: Store in a cool, dry place. Do NOT freeze or refrigerate.
Storage Environment Temperature: between 60 and 80 Degrees Fahrenheit
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a9602d1d-a185-4f8f-81c3-7ce8a200f243
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016