Anti-k

GUDID 00858400005015

Blood Grouping Reagent

AMERICAN NATIONAL RED CROSS

Anti-k (KEL002) red blood cell grouping IVD, antibody
Primary Device ID00858400005015
NIH Device Record Keya5a3cf4e-3210-4d7e-9f98-441cf2481028
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-k
Version Model Number510202
Company DUNS003255213
Company NameAMERICAN NATIONAL RED CROSS
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858400005015 [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 Date2014-11-04

On-Brand Devices [Anti-k]

00858400005015Blood Grouping Reagent
00858400005008Blood Grouping Reagent

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