AIMSTRIP US-K

GUDID 00695684501211

Dipstick reagent strips for the qualitative detection of Ketone in Urine.

GERMAINE LABORATORIES, INC

Urine ketone IVD, kit, colorimetric dipstick, rapid
Primary Device ID00695684501211
NIH Device Record Key4ca260d5-d3dd-465b-aced-7b0095b8782e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMSTRIP US-K
Version Model Number50121
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100695684501211 [Primary]
GS100695684501212 [Unit of Use]

FDA Product Code

JINNitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-27

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