Inocu Swabs CE VRE-01

GUDID 10634853001203

VRE Positive (Van A)

MICROBIOLOGICS INC.

Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control
Primary Device ID10634853001203
NIH Device Record Key329be365-189f-4bab-846d-540d5d221507
Commercial Distribution StatusIn Commercial Distribution
Brand NameInocu Swabs
Version Model NumberCE VRE-01
Catalog NumberCE VRE-01
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 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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110634853001203 [Primary]

FDA Product Code

JTRKit, quality control for culture media

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 [Inocu Swabs]

10634853001302MSSE Negative Control
10634853001296MRSA Negative
10634853001289MRSA Positive
10634853001272Group B Strep Negative
10634853001265Group B Strep Positive
10634853001258CT/GC Swab Validation Set (Chlamydia/GC)
10634853001227VRE Positive (Van B)
10634853001210VRE Negative
10634853001203VRE Positive (Van A)

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