C1 Cleaning Solution C1S500

GUDID 00817439020314

For use as a cleaning solution on the Polychem 180 System. Concentrate formula. Use according to package instructions. 6 x 10 ml

Medtest Dx, Inc.

Wash/cleaning solution IVD, automated/semi-automated system
Primary Device ID00817439020314
NIH Device Record Key6b21c42d-37c1-4fc4-bb52-9edf42f0547a
Commercial Distribution StatusIn Commercial Distribution
Brand NameC1 Cleaning Solution
Version Model NumberC1S500
Catalog NumberC1S500
Company DUNS070371210
Company NameMedtest Dx, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817439020314 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-27

Devices Manufactured by Medtest Dx, Inc.

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00817439020031 - Direct Lipid Control L32018-07-06 This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipopr
00817439020093 - Albumin / BS4802018-07-06 For the quantitative determination of Albumin in serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device. 8
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.
00817439020130 - ALP Reagent2018-07-06 For the quantitative in vitro determination of Alkaline Phosphatase (ALP) in serum and plasma. 6 x 51 ml, 6 x 14 ml

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