FDA.report

Tinto Detector CapGap Plus Slides

Primary DI
B502BSB70060
Brand
Tinto Detector CapGap Plus Slides
Company
BIO SB, INC.
Model
BSB 7006
Catalog number
BSB 7006
Device description
Accessory of the Tinto Stainer Plus Automated System
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KEWSLIDES, MICROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B502BSB70060PrimaryHIBCC0

GMDN Terms

TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)561-1145sales@biosb.com

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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B502BSB0308CS02-Core SV-40 Cell Line Microarray Control SlidesBSB-0308-CSBSB-0308-CS2025-03-18
B502BSB0309CS02-Core HHV-8 Cell Line Microarray Control SlidesBSB-0309-CSBSB-0309-CS2025-03-18
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B502BSB03551000Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-100BSB-0355-1002025-03-18
B502BSB0355150Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-15BSB-0355-152025-03-18
B502BSB035550Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-5BSB-0355-52025-03-18
B502BSB0355500Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-50BSB-0355-502025-03-18
B502BSB03561000Mohs Mouse/Rabbit PolyDetector Plus HRP GreenBSB-0356-100BSB-0356-1002025-03-18

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