FDA.report

Coagulation Optic (Advance)

Primary DI
08426950452805
Brand
Coagulation Optic (Advance)
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00009758080
Catalog number
00009758080
Device description
COAGULOMETRIC OPTIC TEST, ACL FUTURA
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Product Code Classifications

CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08426950452805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08426950452805084269504528058426950452805

GMDN Terms

TermDefinition
Optical instrument performance standard calibrator/control IVD, single-useA reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR instrument). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It may be used to verify pipetting/dispensing/aspiration/diluting functions of liquid-handling instruments, using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-678-0710techsupport@ilww.com

Regulatory Flags

DUNS number
557223252
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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