AccessGUDID - DEVICE: SPOTCHECK (00725609000649)

GUDID

Device Identifier (DI) Information

Brand Name: SPOTCHECK
Version or Model: 85-4000-05K
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85-4000-05K
Company Name: ASTORIA-PACIFIC, INC.

Primary DI Number: 00725609000649
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623238615 *Terms of Use

Device Description: T4 Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of Thyroxine (T4) Levels in Neonates

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:	Yes
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?
59219	Neonatal thyroxine (neonatal T4) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of neonatal thyroxine (neonatal T4) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972974	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e8bf5835-1106-40fe-80bb-0adf941138e1
Public Version Date: December 25, 2020
Public Version Number: 1
DI Record Publish Date: December 17, 2020