FDA.report

SURE-VUE FOBT 100/PK

Primary DI
00613647000670
Brand
SURE-VUE FOBT 100/PK
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
23038031
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KHEREAGENT, OCCULT BLOOD

Product Code Classifications

CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00613647000670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613647000670006136470006706136470006700613647000670

GMDN Terms

TermDefinition
Faecal occult blood IVD, kit, chromogenic, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin) within a short period relative to standard laboratory testing procedures, using a chromogenic method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods

Method

Contacts

PhoneEmail
+018007667000Regulatory.Affairs@thermofisher.com

Regulatory Flags

DUNS number
004321519
Device count
1
DM exempt
false
Premarket exempt
false
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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