FDA.reportPublic FDA data

Fresh Cells

Primary DI
30014613333111
Brand
Fresh Cells
Company
DIAGNOSTIC HYBRIDS, INC.
Model
56-0102
Catalog number
56-0102
Device description
A549 SV/CS
Published
2018-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIRCELLS, ANIMAL AND HUMAN, CULTURED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIRCells, Animal And Human, CulturedHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613333111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333311130014613333111

GMDN Terms#

Term, Definition table
TermDefinition
Cell culture line IVDA cell line of known origin intended to be used alone or in combination with other IVDs, for cytogenetic analyses and/or for the detection/cultivation of viruses present in clinical laboratory specimens.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
117359612
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30014613330288D3 Ultra01-010000.V201-010000.V22019-03-07
30014613330875D3 Fastpoint01-12350401-1235042019-03-07
00050428101735CVS Health At Home COVID-19 Test Kit204522895862025-08-08
30014613340089Savanna20382R20382R2024-07-19
30014613339304Savanna20382203822024-04-30
30014613340188CVS Health At Home COVID-19 Test Kit204522895862024-11-20
30014613330240D301-0005001-000502019-04-02
30014613311034LyraM103M1032016-09-15
30014613311157Quidel MolecularM115M1152018-11-16
30014613330752D3 FastpointRespiratory Virus ID Kit01-1200002016-09-15
30014613330769D3 Fastpoint01-120000.B101-120000.B12018-07-22
30014613330776D3 Fastpoint01-120000.B201-120000.B22018-07-22
30014613330813D3 FastpointRSV/MPV ID Kit01-1200022016-09-15
30014613330820D3 Fastpoint01-120002.B101-120002.B12018-07-22
30014613330837D3 Fastpoint01-120002.B201-120002.B22018-07-22
30014613336143SolanaM306M3062018-08-07
30014613338659D301-002007b01-002007b2019-04-23
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700575016899PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2026-04-29
04015630972524HER2 Dual ISH 3-in-1 Xenograft SlidesVentana Medical Systems, Inc.KIR2021-02-03
04015630971091HER2 3-in-1 Xenograft Control SlidesVentana Medical Systems, Inc.KIR2021-01-29
04015630971909HPV FAMILY 6 SYSTEM CONTROL SLIDES [B]Ventana Medical Systems, Inc.KIR2021-01-29
04015630971961HPV 3 in 1 System Control SlidesVentana Medical Systems, Inc.KIR2021-01-29
05700573001736PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2020-11-17
05700571112755PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2020-11-17
30014613339571Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-10-02
30014613339564Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-09-25
30014613339274Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-07-14
30014613339281Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-07-14
B7829500A07TdT Control Cell SuspensionSupertechs, Inc.KIR2019-10-08
30014613331377Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331384Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331391Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331407Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331414Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331421Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331438Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331445Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331698Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331704Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331711Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331728Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331735Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331742Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331759Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331766Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331773Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331780Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21