GROUP A STREPTOCOCCUS 103890

GUDID 15420045506305

Hologic, Inc.

Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID15420045506305
NIH Device Record Keyd2cd030c-990e-4c01-81ae-0b73cedacee5
Commercial Distribution StatusIn Commercial Distribution
Brand NameGROUP A STREPTOCOCCUS
Version Model NumberGROUP A STREP DIRECT TEST (GASD) 100T
Catalog Number103890
Company DUNS050579217
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045506305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDKDNA-PROBE, REAGENTS, STREPTOCOCCAL

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 Date2016-05-02

On-Brand Devices [GROUP A STREPTOCOCCUS]

15420045506312GROUP A STREP DIRECT TEST (GASD) 500T
15420045506305GROUP A STREP DIRECT TEST (GASD) 100T

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