FDA.reportPublic FDA data

PHOSPHORUS-SL Assay

Primary DI
00628063400843
Brand
PHOSPHORUS-SL Assay
Company
Sekisui Diagnostics, LLC
Model
117-30
Catalog number
117-30
Published
2016-09-20
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
false

Product Codes#

Code, Name table
CodeName
CEOPhosphomolybdate (colorimetric), inorganic phosphorus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEOPhosphomolybdate (Colorimetric), Inorganic PhosphorusClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974858000PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30Diagnostic Chemicals , Ltd.1998-01-30CEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400843006280634008436280634008430628063400843

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic phosphate (PO43-) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen using a spectrophotometry method.

Regulatory Flags#

DUNS number
966812344
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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Primary DI, Brand, Company table
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