FDA.report

INI-1 control slides

Primary DI
B502BSB68340
Brand
INI-1 control slides
Company
BIO SB, INC.
Model
Control Slides, 5
Catalog number
BSB 6834
Device description
INI-1 Control
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LJGQuality Control Slides

Product Code Classifications

CodeDeviceSpecialtyClass
LJGQuality Control SlidesMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B502BSB68340PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
102855447
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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