TOTAL AND DIRECT BILIRUBIN 2130-0

GUDID 00852223007218

TOTAL AND DIRECT BILIRUBIN (MODIFIED MALLOY-EVELYN)

STERLING DIAGNOSTICS INC

Total bilirubin IVD, reagent
Primary Device ID00852223007218
NIH Device Record Key97d26350-f648-4604-9e89-c0ac7ce0ee7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOTAL AND DIRECT BILIRUBIN
Version Model Number2130-0
Catalog Number2130-0
Company DUNS155284151
Company NameSTERLING DIAGNOSTICS 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 Usefalse
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
GS100852223007218 [Primary]

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 Date2016-09-14

Devices Manufactured by STERLING DIAGNOSTICS INC

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00852223007126 - UREA NITROGEN (BERTHELOT)2018-04-17 UREA NITROGEN (BERTHELOT)
00852223007003 - ENZYMATIC CHOLESTEROL2018-03-29 ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH)
00852223007010 - ENZYMATIC CHOLESTEROL2018-03-29 ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH)
00852223007027 - HDL CHOLESTEROL2018-03-29 HDL CHOLESTEROL (PEG METHOD)
00852223007034 - CPK / COLORIMETRIC2018-03-29 CREATINE PHOSPHOKINASE (CPK) COLORIMETRIC
00852223007041 - CREATININE/ ENDPOINT2018-03-29 CREATININE/ENDPOINT
00852223007058 - ENZYMATIC GLUCOSE2018-03-29 GLUCOSE ENZYMATIC TRINDER

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