FDA.reportPublic FDA data

Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays

Primary DI
20816068020201
Brand
Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays
Company
Advanced Instruments, LLC
Model
111010
Catalog number
111010
Device description
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 200 test cartridges.
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
true

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
20816068020201PrimaryGS10
00816068020207Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081606802020120816068020201
00816068020207008160680202078160680202070816068020207

GMDN Terms#

Term, Definition table
TermDefinition
Haematological cell analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
125006353
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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10816068020266Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 103LA0293LA0292020-09-21
10816068020433Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0113LA0112020-09-21
10816068020440Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA1513LA1512020-09-21
10816068020457Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0513LA0512020-09-21
10816068020464Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0913LA0912020-09-21
10816068020471Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA2013LA2012020-09-21
10816068020747Advanced Instruments 3000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA3013LA3012020-09-21
10816068020754Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0003MA0002020-09-21
00816068020832Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 5003LA8253LA8252020-09-21
00816068020504Advanced Instruments Ease-Eject 20-Microliter Sampler3M08253M08252020-09-21
00816068020580Advanced Instruments 2020 Osmometer Probe Wiper Rings2028402028402020-09-21
00816068020597Advanced Instruments 20 µL Pipet2408202408202020-09-21
00816068020610Advanced Instruments A2O Osmometer Probe Wiper Rings2002212002212020-09-21
00816068020627Advanced Instruments Cuvettes2002202002202020-09-21
00816068020634Advanced Instruments A2O System Fluid2002222002222020-09-21
00816068020658Advanced Instruments Swab Cleaners2028502028502020-09-21
00816068020719Advanced Instruments 500 mOsm Calibration Standard - 110 mL Bottle3LA0503LA0502020-09-21
00816068020726Advanced Instruments 900 mOsm Calibration Standard - 110 mL Bottle3LA0903LA0902020-09-21
00816068020733Advanced Instruments 1500 mOsm Calibration Standard - 110 mL Bottle3LA1503LA1502020-09-21
00816068020023Advanced Instruments BR2 Disposable CuvettesB2A800B2A8002016-09-23

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