FDA.reportPublic FDA data

Advanced Instruments GloCyte® High Level Control Vial (Single)

Primary DI
00816068020191
Brand
Advanced Instruments GloCyte® High Level Control Vial (Single)
Company
Advanced Instruments, LLC
Model
111113
Device description
3 mL vial of High Level Control
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPKMixture, Hematology Quality Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

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
00816068020191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020191008160680201918160680201910816068020191

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+17813209000Orders@aicompanies.com

Regulatory Flags#

DUNS number
125006353
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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