Fresh Cells

Primary DI
30014613333579
Brand
Fresh Cells
Company
DIAGNOSTIC HYBRIDS, INC.
Model
62-00050
Catalog number
62-00050
Device description
MNA FROZEN SUSP. 50 MER
Published
2018-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
30014613333579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333357930014613333579

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428101735CVS Health At Home COVID-19 Test Kit204522895862025-08-08
30014613340188CVS Health At Home COVID-19 Test Kit204522895862024-11-20
30014613340089Savanna20382R20382R2024-07-19
30014613339304Savanna20382203822024-04-30
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30
30014613330486D301-01501001-0150102023-07-10
30014613339090LyraCoronavirusM1202021-02-17
30014613339144LyraCoronavirusM1242021-02-17
30014613339656Solana SARS-CoV-2 AssayCoronavirusM3132021-02-17
30014613339571Fresh Cells72-9624C72-9624C2020-10-02
30014613339564Fresh Cells84-010184-01012020-09-25
30014613339236DHI Specimen Collection System6016012020-07-16
30014613339311DHI Specimen Collection System6026022020-07-16
30014613339274Fresh Cells91-969691-96962020-07-14
30014613339281Fresh Cells50-91-9696-9050-91-9696-902020-07-14
30014613336167SolanaM308M3082020-02-04
30014613312147AmpliVueM214M2142020-01-28
30014613312154AmpliVueM215M2152020-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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, INCKIR2019-10-08
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
30014613331797Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331803Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21