Poly stat

GUDID 00855574005438

Strep A, Immunochromatographic, Flip

POLYMEDCO, INC.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00855574005438
NIH Device Record Key3410ad6a-cc96-459d-92dd-867c6c812f04
Commercial Distribution StatusIn Commercial Distribution
Brand NamePoly stat
Version Model NumberSTF25
Company DUNS024798555
Company NamePOLYMEDCO, INC.
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

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
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855574005438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Poly stat]

00816917021546Mono, Immunochromatographic
00855574005438Strep A, Immunochromatographic, Flip
00855574005421Strep A, Immunochromatographic
00855574005414H. Pylori, Immunochromatographic
00855574005407Flu A & B, Immunochromatographic
00855574005391Qualitative HCG Control, Urine
00855574005384HCG, Immunochromatographic Test
00855574005377Qualitative HCG Control
00816917022925Flu A & B, Immunochromatographic, 25 Test Kit

Trademark Results [Poly stat]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POLY STAT
POLY STAT
76061404 2580953 Live/Registered
Polymedco, Inc.
2000-06-01

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