OcculTech Fecal Occult Blood Rapid Test

GUDID 08806125630229

The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices.

YD Diagnostics CORP.

Faecal occult blood IVD, kit, rapid colorimetric, clinical
Primary Device ID08806125630229
NIH Device Record Keydcb24a93-9888-4e62-abd5-cf074ac4f42d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOcculTech Fecal Occult Blood Rapid Test
Version Model NumberIM706-100M
Company DUNS687769737
Company NameYD Diagnostics CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806125630229 [Primary]

FDA Product Code

KHEReagent, Occult Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-11-28
Device Publish Date2019-08-13

Devices Manufactured by YD Diagnostics CORP.

08806125630229 - OcculTech Fecal Occult Blood Rapid Test2022-11-28The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices.
08806125630229 - OcculTech Fecal Occult Blood Rapid Test2022-11-28 The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed fo
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08806125680217 - URiSCAN 10 SGL strip2021-12-22 Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Leucocytes, Nitrite, Urobilinogen, Glucose, pH, B
08806125680224 - URiSCAN 2 ACR strip2021-12-22 Urinalysis dip and read strips for URiSCAN urine analyzer. Test for Microalbumin and Creatinine in urine.
08806125680231 - URiSCAN 10 ACR strip2021-12-22 Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Ketones(Acetoacetic Acid), Protein, Nitrit
08806125680279 - UCARE 11 Stick2021-12-22 Urinalysis dip and read strips for urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein,

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