Research and Diagnostic Systems BFI001

GUDID 00815762020070

R & D Body Fluid-I: 3 x 3mL (1 each Level 1,2,3)

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Full blood count IVD, control
Primary Device ID00815762020070
NIH Device Record Keyb2a5a7b3-041d-4280-8755-32031b381c23
Commercial Distribution StatusIn Commercial Distribution
Brand NameResearch and Diagnostic Systems
Version Model NumberBFI001
Catalog NumberBFI001
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-428-4246
Emailcustomerserviceccd@bio-techne.com
Phone800-428-4246
Emailcustomerserviceccd@bio-techne.com
Phone800-428-4246
Emailcustomerserviceccd@bio-techne.com

Device Dimensions

Total Volume9 Milliliter
Total Volume9 Milliliter
Total Volume9 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100815762020070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPKMixture, Hematology Quality Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-03

On-Brand Devices [Research and Diagnostic Systems]

00815762021961CBC-7 2mL Dual Pack (6 Low, 6 Normal)
00815762021954Platelet-Trol Extended: 3 x 3mL (level 3)
00815762021947Platelet-Trol Extended: 3 x 3mL (level 6)
00815762021930Platelet-Trol Extended: 3 x 3mL (level 4)
00815762021923Platelet-Trol Extended: 3 x 3mL (level 5)
00815762021862CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7 WBC Levels 1-6 PL
00815762021855CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-6 WBC Levels 1-3,5-7 PL
00815762021848CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7 WBC Levels 1-3,5-
00815762021831CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7 WBC Levels 1-6 PL
00815762021824CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6 & 7 WBC Levels 1,3,
00815762021817CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7 WBC Levels 1-3,5-
00815762021800CBC-LINE Kit 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7 WBC Levels 1-6 PLT
00815762021794CBC-LINE Kit 6 x 3mL (6 vials each of the various levels) RBC Levels 1-6 WBC Levels 1-6 PLT Lev
00815762021787CBC-LINE Kit 6 x 3mL (6 vials each of the various levels) RBC Levels 1-6 WBC Levels 1-3,5-7 PLT
00815762021770CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7 WBC Levels 1-3,5-
00815762021763CBC-LINE Kit 6 x 3mL RBC Levels 1-6 WBC Levels 1-6 PLT Levels 1,2,4,5,7,8 Low Levels 1-6
00815762021725FETALtrol 9 x 2 mL (3 level 1, 3 level 2, 3 level3)
00815762021718Human Total 25-OH Vitamin D IVD ELISA Kit
00815762021701FETALtrol 3 x 2mL (1 Level 1, 1 Level 2, 1 Level 3)
00815762021695FETALtrol 6 x 2mL (2 Level 1, 2 level 2, 2 level 3)
00815762021671Quantikine Erythropoietin Control 1 & 2 (5 vials of each)
00815762021657Quantikine IVD Human Soluble Transferrin Receptor ELISA Kit
00815762021640Quantikine IVD Erythropoietin ELISA Kit
00815762021633XERET: 6 X 3.0mL TriPack (2 each Level 1,2,3)
00815762021626Ultra Low Range Kit Plus RBC (6 x 3mL Ultra Low RBC, 6 x 3mL Ultra Low)
00815762021619Ultra Low Range Kit: 6 x 3mL (Levels 1-6)
00815762021596StatusFlowPro: 2 x 1.5mL (1 Low & 1 High)
00815762021558StatusFlowPro: 1 x 1.5mL (Low Level)
00815762021541StatusFlowPro: 1 x 1.5mL (High Level)
00815762021527StatusFlowLo Control: 1 x 2.5mL
00815762021442R&D Sickle QC: 4 x 2.5mL (2 each Level 1, 2)
00815762021435R&D Sickle QC: 2 x 2.5mL (1 each Level 1, 2)
00815762021428SedRite Plus: 2 X 4.5ml (1 each level 1,2)
00815762021411SedRite Plus: 12 x 4.5mL Tube (6 each Level 1,2)
00815762021404SedRite Plus: 4 x 9mL (2 each Level 1,2)
00815762021398SedRite Plus: 8 x 9mL (4 each Level 1,2)
00815762021343SedRite III: 8 x 9mL (4 each Level 1,2)
00815762021336SedRite III: 4 x 9mL (2 each Level 1,2)
00815762021312"RET-LINE B 7 x 2.5mL (one of each level 1-6 + 1 base)"
00815762021305RET-LINE Kit 8 x 2.5mL Reticulocyte Levels 1-8
00815762021299R&D Retic-I Plus: 9 x 4mL Tubes (3 each Level 1, 2, 3)
00815762021282R&D Retic-I Plus: 3 x 4mL Tubes (1 each Level 1, 2, 3)
00815762021275Retic-I DxH-800: 9 x 3mL TriPack Tubes (3 each Level 1,2,3)
00815762021268Retic-I DxH-800: 3 x 3mL TriPack Tubes (1 each Level 1,2,3)
00815762021251R&D Retic-I: 3 x 1.5mL TriPack Vials (1 each Level 1,2,3)
00815762021244R&D Retic-I: 3 x 3mL TriPack Tubes (1 each Level 1,2,3)
00815762021237R&D Retic-I: 9 x 3mL TriPack Tubes (3 each Level 1,2,3)
00815762021220R&D Retic-I: 9 x 1.5mL TriPack Vials (3 each Level 1,2,3)
00815762021213R&D Retic: 3 x 1.5mL TriPack (1 Each Level 1,2,3)
00815762021206R&D Retic: 9 x 1.5mL TriPack (3 Each Level 1,2,3)

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