FDA.reportPublic FDA data

Phosphate (Inorganic) ver.2

Primary DI
07613336121481
Brand
Phosphate (Inorganic) ver.2
Company
Roche Diagnostics GmbH
Model
08058610190
Catalog number
08058610190
Published
2020-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K983503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983503000ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347Boehringer Mannheim Corp.1998-12-01CEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121481076133361214817613336121481

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 quantitative measurement of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
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00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
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