Thermo Scientific Infinity™

GUDID 00845275003444

Fisher Diagnostics

Angiotensin converting enzyme (ACE) IVD, calibrator
Primary Device ID00845275003444
NIH Device Record Key728c8c1a-1fcd-431f-82de-1be200419d7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermo Scientific Infinity™
Version Model NumberTR85201
Company DUNS183998769
Company NameFisher Diagnostics
Device Count6
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-528-0494
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845275003444 [Primary]
GS100845275006292 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JISCalibrator, Primary

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 Date2016-09-16

On-Brand Devices [Thermo Scientific Infinity™]

00845275003444TR85201
00845275003420TR85056
00845275003383TR70121
00845275003352TR66056
00845275003314TR60901
00845275003239TR50001
00845275003031TR35121
00845275002751TR25421
00845275002423TR15421
00845275002409TR15221
008452750010821265250
00845275000429TR66901
00845275000351TR12421
00845275000047TR28321

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