| Primary Device ID | 30014613335061 |
| NIH Device Record Key | fcc3776f-6bb6-4b4f-94fd-19e155c809e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fresh Cells |
| Version Model Number | 97-0101 |
| Catalog Number | 97-0101 |
| 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 |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30014613335061 [Primary] |
| KIR | CELLS, ANIMAL AND HUMAN, CULTURED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-09-21 |
| 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 |