MAGLUMI 2000 TSH 130603013M

GUDID 06947145500023

Shenzhen New Industries Biomedical Engineering Co., Ltd.

Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Primary Device ID06947145500023
NIH Device Record Key47d84b52-a29f-4721-a066-ed3e55cee5d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAGLUMI 2000 TSH
Version Model Number130603013M
Catalog Number130603013M
Company DUNS421745241
Company NameShenzhen New Industries Biomedical Engineering Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106947145500023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JLWRadioimmunoassay, Thyroid-Stimulating Hormone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-10
Device Publish Date2022-08-02

On-Brand Devices [MAGLUMI 2000 TSH]

06947145500023130603013M
06947145500016130203013M

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