bkt ß-Ketone Test Strips (50 pcs/box)

GUDID 00860005745913

Adam Lawrence

Ketone (acetoacetate) IVD, reagent
Primary Device ID00860005745913
NIH Device Record Key5d756ca2-3261-4004-945a-542c222610a9
Commercial Distribution StatusIn Commercial Distribution
Brand Namebkt ß-Ketone Test Strips (50 pcs/box)
Version Model NumberTD-4279
Company DUNS117734901
Company NameAdam Lawrence
Device Count1
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860005745913 [Primary]

FDA Product Code

JINNitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-21
Device Publish Date2022-10-13

Devices Manufactured by Adam Lawrence

00860005745913 - bkt ß-Ketone Test Strips (50 pcs/box)2022-10-21
00860005745913 - bkt ß-Ketone Test Strips (50 pcs/box)2022-10-21
00858538007127 - bkt ß-Ketone & blood glucose monitoring system2022-09-19 Glucose Test strip 10 PCS Ketone Test strip 10 PCS Lancing device 1 PCS Lancet 10PCS
00860005745944 - bkt ß-Ketone & blood glucose monitoring system2021-03-23
00860005745906 - bkt ß-Ketone Test Strips (100 pcs/box)2020-12-30
00860005745920 - bkt Blood Glucose Test Strips (50pcs/box)2020-12-30

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