MedTest DX Magnesium on the BS200 MAG600

GUDID 00817439021120

For the quantitative determination of magnesium in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only.

Medtest Dx, Inc.

Magnesium (Mg2+) IVD, reagent
Primary Device ID00817439021120
NIH Device Record Key3d497d69-6e70-492a-a609-8b143fd72549
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedTest DX Magnesium on the BS200
Version Model NumberMAG600
Catalog NumberMAG600
Company DUNS070371210
Company NameMedtest Dx, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817439021120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JGJPhotometric Method, Magnesium

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-27

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00817439020109 - Albumin2018-07-06 For the quantitative in vitro determination of Albumin in serum and plasma on the Polychem 180 analyzer. 9 x 51 ml
00817439020116 - Albumin / BS2002018-07-06 For the quantitative determination of Albumin in serum using the Mindray BS-200 analyzer. 4 x 40 ml
00817439020123 - Alkaline Phos/ BS4802018-07-06 For the quantitative determination of Albumin in serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device.
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