FDA.reportPublic FDA data

CEROS

Primary DI
00858604006719
Brand
CEROS
Company
HAMILTON THORNE, INC.
Model
CEROS
Device description
A modular computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality.
Published
2019-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GKLCounter, Cell, Automated (Particle Counter)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKLCounter, Cell, Automated (Particle Counter)Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920719000IVOS ANALYZERHamilton Thorne Research1992-06-29GKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858604006719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858604006719008586040067198586040067190858604006719

GMDN Terms#

Term, Definition table
TermDefinition
Spermatozoa/semen analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of a semen specimen to assess volume, spermatozoa concentration, motility and/or morphological characteristics. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
152161337
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858604006061Intelligent ICSI MicropipetteIC.3.90.xx.B2024-12-11
00858604006054LYKOS DTSLYKOS DTS2023-06-07
00858604006276ZILOS-tk™ZILOS-tk2019-11-30
00858604006290LYKOS™LYKOS2019-11-30
00858604006108IVOSIVOS2019-11-30
00858604006016accu-beads®accu-beads®2022-03-30
00858604006115GM501 Gradient 45%4GM501GR-45-102021-04-30
00858604006122GM501 Gradient 45%4GM501GR-45-502021-04-30
00858604006139GM501 Gradient 45%4GM501GR-45-1002021-04-30
00858604006221GM501 Gradient 100%4GM501G-100-1002021-04-30
00858604006238GM501 Gradient 100%4GM501G-100-2502021-04-30
00858604006245GM501 Gradient 100%4GM501G-100-5002021-04-30
00858604006146GM501 Gradient 45%4GM501GR-45-2502021-04-30
00858604006177GM501 Gradient 90%4GM501GR-90-102021-04-30
00858604006184GM501 Gradient 90%4GM501GR-90-502021-04-30
00858604006191GM501 Gradient 90%4GM501GR-90-1002021-04-30
00858604006207GM501 Gradient 90%4GM501GR-90-2502021-04-30
00858604006214GM501 Gradient 100%4GM501G-100-502021-04-30
00858604006351Intelligent ICSI MicropipetteIC.4.70.xx.C2020-02-19
00858604006320Intelligent ICSI MicropipetteIC.3.45.xx.A2019-11-20

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