FDA.report

Fresh Cells

Primary DI
30014613333364
Brand
Fresh Cells
Company
DIAGNOSTIC HYBRIDS, INC.
Model
57-9696
Catalog number
57-9696
Device description
HEP-2 W96/96
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

Related Records

Contact Domains

Product Codes

CodeName
KIRCELLS, ANIMAL AND HUMAN, CULTURED

Product Code Classifications

CodeDeviceSpecialtyClass
KIRCells, Animal And Human, CulturedHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30014613333364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3001461333336430014613333364

GMDN Terms

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

Contacts

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

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30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
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30014613339144LyraCoronavirusM1242021-02-17
30014613339656Solana SARS-CoV-2 AssayCoronavirusM3132021-02-17
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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

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