FDA.reportPublic FDA data

Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit

Primary DI
10816068020211
Brand
Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit
Company
Advanced Instruments, LLC
Model
111011
Catalog number
111011
Device description
The GloCyte Red Blood Cell (RBC) Reagent is a non-automated in-vitro diagnostic device intended to stain erythrocytes for quantitative enumeration of RBCs in human cerebrospinal fluid (CSF) specimens collected from adult and pediatric patients. The reagent is intended to be used by trained healthcare professionals in clinical laboratories as an aid in diagnosis for neurological diseases such as a meningeal infection, subarachnoid hemorrhage, central nervous system malignancy, and demyelinating disease. For use on the GloCyte Automated Cell Counter System only.
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
10816068020211PrimaryGS10
00816068020214Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081606802021110816068020211
00816068020214008160680202148160680202140816068020214

GMDN Terms#

Term, Definition table
TermDefinition
Red cell antibody eluting IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in the process of eluting antibodies bound to antigens present on the surface of red blood cells of a clinical specimen.

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
3
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Company table
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