FDA.report

PSAP Control Slides

Primary DI
B502BSB59090
Brand
PSAP Control Slides
Company
BIO SB, INC.
Model
Control Slides, 5
Catalog number
BSB 5909
Device description
PSAP, 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
B502BSB59090PrimaryHIBCC0

GMDN Terms

TermDefinition
Metachromatic leukodystrophy IVD, controlA material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inherited disorder metachromatic leukodystrophy, an inherited disorder associated with progressive destruction of the white matter of the nervous system due to mutation in the arylsulfatase A (ARSA) and prosaposin (PSAP) genes.

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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