AccessGUDID - DEVICE: Thyroid Stimulating Hormone (TSH) Ultrasensitive ELISA (B24225TSHHUUE010)

GUDID

Device Identifier (DI) Information

Brand Name: Thyroid Stimulating Hormone (TSH) Ultrasensitive ELISA
Version or Model: 25-TSHHUU-E01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 25-TSHHUU-E01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24225TSHHUUE010
Issuing Agency: HIBCC
Commercial Distribution End Date: February 19, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The Thyroid Stimulating Hormone (TSH) Ultrasensitive ELISA is intended for use in the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.

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?
54383	Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: e5d717d8-8e2a-451f-a45c-eac729cb1893
Public Version Date: September 20, 2022
Public Version Number: 4
DI Record Publish Date: August 03, 2017