FDA.reportPublic FDA data

Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume

Primary DI
00816068020016
Brand
Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume
Company
Advanced Instruments, LLC
Model
806053
Catalog number
806053
Device description
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Used for aspirating and dispensing sample and reagents.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K152776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152776000Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.2016-05-27GKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816068020016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020016008160680200168160680200160816068020016

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical pipetteA manually-operated device typically used in the laboratory to withdraw, transfer, and inject discrete volumes of fluid materials. The device is typically hand-held and operates through an internal mechanism powered by the fingers; it can have a single channel or multichannel piston/cylinder pick-up assembly. The device transfers consistent volumes of liquid into one or several receptacles simultaneously (e.g., the wells of a microtitre plate). A pipette may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range. The delivered volume may be mechanically indicated.

Contacts#

Phone, Email table
PhoneEmail
+1-781-894-0800info@novabio.com

Regulatory Flags#

DUNS number
125006353
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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