VITROS 8112724

GUDID 10758750004393

VITROS Chemistry Products AMYL Slides

ORTHO-CLINICAL DIAGNOSTICS, INC.

Total amylase IVD, reagent
Primary Device ID10758750004393
NIH Device Record Keyd5128005-9325-480e-ab76-312f81f5ea82
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITROS
Version Model Number8112724
Catalog Number8112724
Company DUNS623873044
Company NameORTHO-CLINICAL DIAGNOSTICS, 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

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
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
GS110758750004393 [Primary]

FDA Product Code

CIWSTARCH-DYE BOUND POLYMER, AMYLASE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-06-21
Device Publish Date2016-08-23

On-Brand Devices [VITROS]

10758750032105VITROS Chemistry Products Calibrator Kit 32
10758750031801VITROS XT Chemistry Products TBIL-ALKP Slides
10758750031795VITROS XT Chemistry Products GLU-Ca Slides
10758750031788VITROS XT Chemistry Products UREA-CREA Slides
10758750031764VITROS XT Chemistry Products TRIG-CHOL Slides
10758750030736VITROS Chemistry Products Calibrator Kit 31
10758750002832VITROS Chemistry Products Calibrator Kit 30
10758750032136VITROS Chemistry Products ALTV Slides
10758750031108VITROS Chemistry Products LDHI Slides
10758750009602VITROS Chemistry Products AMON Slides
10758750009527VITROS Chemistry Products CHOL Slides
10758750009510VITROS Chemistry Products LIPA Slides
10758750009480VITROS Chemistry Products ALT Slides
10758750009244VITROS Chemistry Products Fe Slides
10758750009220VITROS Chemistry Products PHOS Slides
10758750008957VITROS Chemistry Products Liquid Performance Verifier II
10758750008889VITROS Chemistry Products TRIG Slides
10758750006977VITROS Chemistry Products %A1c Performance Verifier II
10758750006960VITROS Chemistry Products %A1c Performance Verifier I
10758750006908VITROS Chemistry Products PALB Reagent
10758750006878VITROS Chemistry Products ApoB Reagent
10758750006861VITROS Chemistry Products ApoA1 Reagent
10758750006793VITROS Chemistry Products dLDL Reagent
10758750005208VITROS Chemistry Products CRP Performance Verifier I
10758750005154VITROS Chemistry Products Isoenzyme Performance Verifier II
10758750005123VITROS Chemistry Products Isoenzyme Performance Verifier I
10758750005062VITROS Chemistry Products CRP Performance Verifier II
10758750004959VITROS Chemistry Products Liquid Performance Verifier I
10758750004911VITROS Chemistry Products LAC Slides
10758750004768VITROS Chemistry Products TRIG Slides
10758750004683VITROS Chemistry Products LIPA Slides
10758750004638VITROS Chemistry Products GGT Slides
10758750004577VITROS Chemistry Products Performance Verifier II
10758750004454VITROS Chemistry Products LAC Slides
10758750004317VITROS Chemistry Products Performance Verifier I
10758750004225VITROS Chemistry Products CHE Slides
10758750002825VITROS Chemistry Products dHDL Slides
10758750002733VITROS Chemistry Products ASO/RF Performance Verifier II
10758750002726VITROS Chemistry Products ASO/RF Performance Verifier I
10758750002573VITROS Chemistry Products AAT/HPT Performance Verifier III
10758750002566VITROS Chemistry Products AAT/HPT Performance Verifier II
10758750002559VITROS Chemistry Products AAT/HPT Performance Verifier I
10758750002306VITROS Chemistry Products ASO Reagent
10758750001873VITROS Chemistry Products dTIBC Reagent
10758750001668VITROS Chemistry Products dHDL Slides
10758750001385VITROS Chemistry Products ApoB Performance Verifier I
10758750001378VITROS Chemistry Products ApoA1 Performance Verifier I
10758750000289VITROS Chemistry Products Fe Slides
10758750000241VITROS Chemistry Products CHE Slides
10758750000012VITROS Chemistry Products AMON Slides

Trademark Results [VITROS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VITROS
VITROS
87764891 5492323 Live/Registered
Crimson U.S. Assets LLC
2018-01-22
VITROS
VITROS
87202232 5204885 Live/Registered
Crimson U.S. Assets LLC
2016-10-13
VITROS
VITROS
75142862 2126793 Live/Registered
CRIMSON U.S. ASSETS LLC
1996-07-31

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