FDA.report

Fisherbrand

Primary DI
20613647020436
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
08-802
Catalog number
088015
Device description
AFB STAIN CONTROL SLIDE 50/PK
Published
2022-12-07
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
true

Related Records

Contact Domains

Product Codes

CodeName
LJGQUALITY CONTROL SLIDES

Product Code Classifications

CodeDeviceSpecialtyClass
LJGQuality Control SlidesMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20613647020436PackageGS11In Commercial Distribution
00613647020432PrimaryGS10
10613647020439Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702043620613647020436
00613647020432006136470204326136470204320613647020432
1061364702043910613647020439

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

Contacts

PhoneEmail
+1(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags

DUNS number
004321519
Device count
50
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20613647018846Fisherbrand23101000231010002025-04-30
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20613647018877Fisherbrand23101003231010032025-04-30
20613647018884Fisherbrand23101004231010042025-04-30
20613647018891Fisherbrand23101005231010052025-04-30
20613647024847Fisherbrand19-041-372B19041372B2025-04-30
30613647024851Fisherbrand19-041-372C19041372C2025-04-30
20613647024861Fisherbrand19-041-372D19041372D2025-04-30

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