Test Kits 60060

GUDID 10634853001340

ID-AE KIT

MICROBIOLOGICS INC.

Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, colorimetric, rapid Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical Pyroglutamyl aminopeptidase (PAP)/nitrophenylalanine deaminase (NPA) activity IVD, kit, rapid colorimetric, clinical
Primary Device ID10634853001340
NIH Device Record Key6a77c127-d978-46d9-bf3a-40c99250d9d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTest Kits
Version Model Number60060
Catalog Number60060
Company DUNS060467826
Company NameMICROBIOLOGICS 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 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

Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com

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
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
GS110634853001340 [Primary]

FDA Product Code

JTODiscs, strips and reagents, microorganism differentiation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-04
Device Publish Date2022-09-26

On-Brand Devices [Test Kits]

10634853001357Oxidase Swabs
10634853001340ID-AE KIT
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