Fresh Cells 53-T225

GUDID 30014613338413

BGMK FLK 225 SQ CM

DIAGNOSTIC HYBRIDS, INC.

Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD

• Primary Device ID: 30014613338413
• NIH Device Record Key: b67fce87-59d5-4b23-99da-53247f882a88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fresh Cells
• Version Model Number: 53-T225
• Catalog Number: 53-T225
• Company DUNS: 117359612
• Company Name: DIAGNOSTIC HYBRIDS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613338413 [Primary]

FDA Product Code

• KIR: CELLS, ANIMAL AND HUMAN, CULTURED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-15
• Device Publish Date: 2019-03-07

On-Brand Devices [Fresh Cells]

• 30014613338420: Super-BGMK FLK 225 SQ CM
• 30014613338413: BGMK FLK 225 SQ CM
• 30014613338307: RHMK FLK 225
• 30014613338260: MDCK FLASK 225 SQ CM
• 30014613335627: CITES RHMK FLK
• 30014613335610: CITES KIDNEY RHESUS TUBE W/A
• 30014613335603: CITES KIDNEY RHESUS SV W/C AN
• 30014613335597: RHMK P1 FROZEN SUSP. CITES
• 30014613335511: MADIN-DARBY CANINE KIDNEY T150
• 30014613335504: MADIN-DARBY CANINE KIDNEY T75
• 30014613335498: MADIN-DARB CAN KIDNEY W96/96
• 30014613335481: MADIN-DARBYCANI KIDNEYW96/60
• 30014613335474: MADIN-DARBY CANI KIDW384/384
• 30014613335429: H&V MIX CELLS MWP 96/96 FILL
• 30014613335412: H&V MIX CELLS MWP 96/24 CUST
• 30014613335405: H&V MIX CELLS MWP 96/12 CUST
• 30014613335399: H&V MIX CELLS MWP W48/36F
• 30014613335382: H&V MIX CELLS MWP W48/24F
• 30014613335375: H&V MIX CELLS MWP W48/18F
• 30014613335368: H&V-MIX MWP W48/12F CUST FILL
• 30014613335351: H&V-MIX MWP W48/12F
• 30014613335344: H&V MIX CELLS MWP 48/08 FILL
• 30014613335337: H&V MIX W48/06 CUST FILL
• 30014613335320: H&V MIX W48/06
• 30014613335313: H&V-MIX MWP W24/24F
• 30014613335306: H&V-MIX MWP W24/18F
• 30014613335290: H&V-MIX MWP W24/12F
• 30014613335283: H&V-MIX MWP W24/09F
• 30014613335276: H&V-MIX MWP W24/06F
• 30014613335269: H&V MIX SV/CS
• 30014613335252: H&V MIX SV
• 30014613335245: R-MIX TOO MWP W96/96
• 30014613335238: R-MIX TOO MWP W96/60F
• 30014613335221: R-MIX TOO MWP W96/48F
• 30014613335214: R-MIX TOO PLATES
• 30014613335207: R-MIX TOO MWP W48/24F
• 30014613335191: R-MIX TOO MWP W48/18
• 30014613335184: R-MIX TOO MW PLT 48W/16FC
• 30014613335177: R-MIX TOO MWP W48/12F
• 30014613335160: R-MIX TOO CELLS MWP 48/08 FILL
• 30014613335153: R-MIX TOO MWP W48/06F
• 30014613335146: R-MIX TOO MWP W24/24F
• 30014613335139: R-MIX TOO MWP W24/24F
• 30014613335122: R-MIX TOO MWP W24/18F
• 30014613335115: R-MIX TOO MWP W24/12F W/CS
• 30014613335108: R-MIX TOO MWP W24/12F
• 30014613335092: R-MIX TOO MW PLATES 24W6F
• 30014613335085: R-MIX TOO 6 WELL 6 FILL
• 30014613335078: R-MIX TOO SV/CS
• 30014613335061: R-MIX TOO SV NO CS