Status Strep A Plus BSP-185-05-00

GUDID 10743816000860

Status Strep A Plus; 5 Test kit (5 Test Strip Canister)

PRINCETON BIOMEDITECH CORPORATION

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Primary Device ID10743816000860
NIH Device Record Key4028bf03-a45b-4705-a9c5-3faa166fbdb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameStatus Strep A Plus
Version Model NumberBSP-185-05-00
Catalog NumberBSP-185-05-00
Company DUNS362917692
Company NamePRINCETON BIOMEDITECH CORPORATION
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 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

Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110743816000860 [Primary]

FDA Product Code

GTYAntigens, All Groups, Streptococcus Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2016-09-23

On-Brand Devices [Status Strep A Plus]

10743816000860Status Strep A Plus; 5 Test kit (5 Test Strip Canister)
10743816000853Status Strep A Plus; 50 Test kit (2 x 25 Test Strip Canister)

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