StrepPRO™ PL039HD

GUDID 00819398027939

StrepPRO™ Extraction Reagent 3, for the rapid latex agglutination test, 60 tests Extraction 1 Reagent for the rapid latex agglutination test for the identification of streptococcal groups.

HARDY DIAGNOSTICS

Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent Beta-haemolytic Streptococcus serological grouping IVD, reagent
Primary Device ID00819398027939
NIH Device Record Key98744bb3-3584-4ae7-9e17-1f91da9e476b
Commercial Distribution StatusIn Commercial Distribution
Brand NameStrepPRO™
Version Model NumberPL039HD
Catalog NumberPL039HD
Company DUNS039981550
Company NameHARDY DIAGNOSTICS
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

Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100819398027939 [Primary]

FDA Product Code

GTZAntisera, All Groups, Streptococcus Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-10
Device Publish Date2020-09-02

On-Brand Devices [StrepPRO™]

00819398027984StrepPRO™ Streptococcal Grouping Kit, rapid latex agglutination test for Streptococcus Lancefi
00819398027946StrepPRO™ Positive Control, for the rapid latex agglutination test, 60 tests Positive Control
00819398027939StrepPRO™ Extraction Reagent 3, for the rapid latex agglutination test, 60 tests Extraction 1
00819398027922StrepPRO™ Extraction Reagent 2, for the rapid latex agglutination test, 60 tests, Extraction 2
00819398027915StrepPRO™ Extraction Reagent 1, for the rapid latex agglutination test, 60 tests Extraction 1
00819398027908StrepPRO™ Grouping Reagent G, for the rapid latex agglutination test, 60 tests Grouping reagen
00819398027892StrepPRO™ Grouping Reagent F, for the rapid latex agglutination test, 60 test Grouping reagent
00819398027885StrepPRO™ Grouping Reagent D, for the rapid latex agglutination test, 60 tests Grouping reagen
00819398027878StrepPRO™ Grouping Reagent C, for the rapid latex agglutination test, 60 tests Grouping reagen
00819398027861Grouping Reagent B, for the rapid latex agglutination test, 60 tests Grouping reagent for the ra
00819398027854Grouping Reagent A, for the rapid latex agglutination test, 60 tests Grouping reagent for the ra
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