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
00816068020900Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V)Anoxomat III (100V - 120V)Anoxomat III (100V - 120V)2020-09-21
00816068020917Advanced Instruments Ergonomic Culture Jar, SmallAJ9049AJ90492020-09-21
00816068020924Advanced Instruments Ergonomic Culture Jar, LargeAJ9050AJ90502020-09-21
00816068020948Advanced Instruments Standard Anoxomat Jar, MediumAJ9025AJ90252020-09-21
00816068020955Advanced Instruments Standard Anoxomat Jar, LargeAJ9028AJ90282020-09-21
00816068020962Advanced Instruments Palladox Disposable SatchetAN3146AN31462020-09-21
00816068020023Advanced Instruments BR2 Disposable CuvettesB2A800B2A8002016-09-23
00816068020030Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and CuvettesB2A101B2A1012016-09-23
00816068020047Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and CuvettesB2A102B2A1022016-09-23
00816068020054Advanced Instruments BR2 Bilirubin Stat-AnalyzerBR2BR22016-09-23
00816068020078Advanced Instruments BR2 Sample DiluentB2A101D2016-09-23
00816068020085Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent SolutionB2A101H2016-09-23
00816068020092Advanced Instruments BR2 5mg/dL Bilirubin Equivalent SolutionB2A101L2016-09-23
00816068020108Advanced Instruments BR2 Sodium NitriteB2A102N2016-09-23
00816068020115Advanced Instruments BR2 Sulfanilic AcidB2A102S2016-09-23
00816068020122Advanced Instruments BR2 Hydrochloric AcidB2A102Y2016-09-23
10816068020174Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene8000978000972016-09-23
10816068020211Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit1110111110112016-09-23
00816068020535Advanced Instruments RBC Reagent Filtration Kit1110141110142021-05-21
00816068020856Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit1112801112802020-07-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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