FDA.reportPublic FDA data

Advanced Instruments GloCyte® Controls Kit

Primary DI
00816068020238
Brand
Advanced Instruments GloCyte® Controls Kit
Company
Advanced Instruments, LLC
Model
111013
Catalog number
111013
Device description
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Low and High Level Control Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains one 3mL vial of Low Level Control and one 3mL 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
OTC
false
Sterile
false
Single use
false

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
00816068020238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020238008160680202388160680202380816068020238

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 Temperature00

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015924209ST 201 Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00860015924216ST 201-B Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00860015924223ST 201-C Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00630414290058Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290065Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290072Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290089Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290096Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290102Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290119Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290126Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323640Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323657Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323534Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323541Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323558Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323565Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323572Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323589Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00860001900538IntelliSep Quality Control KitCytovale IncJPK2025-07-03
00815762026362Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-06
00815762026508Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-04
03610230008584BFTROLHORIBA ABX SASJPK2024-09-26
03610230009581ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009598ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009604ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
00868556000215HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000239HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000246HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000253HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04