Poly stat

GUDID 00816917021546

Mono, Immunochromatographic

POLYMEDCO, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00816917021546
NIH Device Record Key49df58ec-4fed-407b-b211-fbb840e02412
Commercial Distribution StatusIn Commercial Distribution
Brand NamePoly stat
Version Model NumberMN20
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
GS100816917021546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTNSystem, Test, Infectious Mononucleosis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
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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