Research and Diagnostic Systems DEP00

GUDID 00815762021640

Quantikine IVD Erythropoietin ELISA Kit

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Erythropoietin (EPO) IVD, control Erythropoietin (EPO) IVD, control Erythropoietin (EPO) IVD, control

• Primary Device ID: 00815762021640
• NIH Device Record Key: 7f7d19de-7812-4598-8553-29be4bd39b35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Research and Diagnostic Systems
• Version Model Number: DEP00
• Catalog Number: DEP00
• Company DUNS: 087248183
• Company Name: RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-343-7475
• Email: techsupport@bio-techne.com
• Phone: 1-800-343-7475
• Email: techsupport@bio-techne.com
• Phone: 1-800-343-7475
• Email: techsupport@bio-techne.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815762021640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K936016

FDA Product Code

• GGT: Assay, Erythropoietin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-29

On-Brand Devices [Research and Diagnostic Systems]

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