FDA.reportPublic FDA data

Acid Fast Control Slide (pack of 10 slides)

Primary DI
03661540300394
Brand
Acid Fast Control Slide (pack of 10 slides)
Company
ELITECHGROUP INC.
Model
SS-249SAM
Catalog number
SS-249SAM
Device description
Colored slides to be used with Aerospray® TB slide stainer/cytocentrifuges to aid in identifying cells.
Published
2023-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LJGQuality Control Slides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJGQuality Control SlidesMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540300394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540300394036615403003943661540300394

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain control IVDA prepared slide(s) and/or other associated material(s) used to verify the performance of a stain or staining kit that is intended to be used for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
052423787
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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03661540300301Excyte® ESR Non-Vacuum Tubes, CartonEX-50100EX-501002023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonEX-50205EX-502052023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonEP-10605EP-106052023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonEP-10605-H1EP-10605-H12023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerPRD-MSS-EL-08TKNEPRD-MSS-EL-08TKNE2023-10-01
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03661540300202Monosed® ESR Vacuum TubesPRD-PRV11B-50PRD-PRV11B-502023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonPRD-PRV11V-H12PRD-PRV11V-H122023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesEX-50100EX-501002023-10-01
03661540300257Excyte® ESR Vacuum TubesEX-50205EX-502052023-10-01
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