R&D CBC-XR Hematology Control

GUDID 00815762020537

CBC-XR 12 x 4.5 mL (4 each Levels 1, 2 and 3)

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Full blood count IVD, control
Primary Device ID00815762020537
NIH Device Record Keydb9f37db-a0b8-42f7-bf6b-e62c541898bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameR&D CBC-XR Hematology Control
Version Model NumberXR004
Company DUNS087248183
Company NameRESEARCH AND DIAGNOSTIC SYSTEMS, 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
GS100815762020537 [Primary]

FDA Product Code

JPKMixture, Hematology Quality Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-10
Device Publish Date2024-04-02

On-Brand Devices [R&D CBC-XR Hematology Control]

00815762020605CBC-XR 6 x 4.5 mL (2 each Levels 1, 2 and 3)
00815762020537CBC-XR 12 x 4.5 mL (4 each Levels 1, 2 and 3)
00815762020520CBC-XR 10 x 4.5 mL (5 each Levels 2 and 3)

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